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| Sep 23, 2026 | LED Face Mask Manufacturers Worth Considering in 2026: OEM & ODM Guide | LED Face Mask Manufacturer
LED Face Mask
TLM200-K LED Face Mask AR, UNITED STATES, September 23, 2026 /EINPresswire.com/ -- LED Face Mask Manufacturers Worth Considering in 2026: OEM & ODM Guide for Beauty Device Brands
For beauty devic... |
| Aug 4, 2026 | DRX9000-SL® Receives Australian Regulatory Clearance, Expanding Access to Advanced Non-Surgical Spinal Decompression | DRX9000-SL Spinal Decompression Table Now Available for sale to Australia
DRX9000C-SL Cervical Non-Surgical Spinal Decompression Table.jpeg
DRX9000-SL Lumbar and Cervical Spinal Decompression Table
DRX9000-SL Lumbar Spinal Decompression Tab... |
| Aug 2, 2026 | New Chemotherapy-Free Immunotherapy Combination for Follicular Lymphoma Listed on the PBS | Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen listed on the Pharmaceutical Benefits Scheme (PBS) for adults with... |
| Jul 16, 2026 | Samsung Bioepis Grows Australia Biosimilar Portfolio to Four as PBS Default Reform Nears | By Henry Baker
Published: Jul 16 2026, 11:01 AM EDT
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| Jul 16, 2026 | Australia Nutritional Supplements Market Growth Analysis and Forecast Report 2026-2034 | Market Overview
The Australia nutritional supplements market size reached USD 14.5 Billion in 2025 and is projected to reach USD 28.8 Billion by 2034, growing at a compound annual growth rate (CAGR) of 7.64% from 2026 to 2034. The market is... |
| May 31, 2026 | Why Trump reversed course to fast-track psychedelic drugs for mental healthcare | President Donald Trump aims to fast-track research into psychedelic therapy for conditions like post traumatic stress disorder and depression in a break from his first administration policy.
Advocates see the move as a major step forward, b... |
| May 26, 2026 | Nine News Sunscreen Broadcast Flag Internal TGA Concerns, Prompting Calls for ACCC Scrutiny of "Kids" Marketing | Nine News investigates TGA FOI's and ingredients 4-MBC and Homosalate
TGA documents featured on Nine News acknowledge 4-MBC risks, raising questions if the ACCC will scrutinise the marketing of these chemicals in "Kids" products.
... |
| May 6, 2026 | Norgine welcomes TGA registration in Australia of PEDMARQSI® (sodium thiosulfate anhydrous) for the prevention of cisplatin-induced hearing loss in children1 | PEDMARQSI® is now TGA registered in Australia for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to |
| Apr 23, 2026 | MINJUVI® (tafasitamab) for Relapsed or Refractory Follicular Lymphoma Approved in Australia | Minjuvi® (tafasitamab), in combination with rituximab and lenalidomide, is the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for adults with relapsed or refractory... |
| Feb 10, 2026 | WAT Medical's EmeTerm Wearable Device Demonstrates Superior Control of Moderate to Severe Postoperative Nausea and Vomiting in JAMA Surgery-Published Clinical Trial | VANCOUVER, BC, Feb. 10, 2026 /PRNewswire/ -- WAT Medical is proud to announce the publication of a landmark randomized clinical trial in JAMA Surgery, one of the world's most reputable and high-impact surgical journals. The study confirms t... |
| Jan 20, 2026 | Chinese NMPA Accepts New Drug Application for Illuccix for Prostate Cancer Imaging | MELBOURNE, Australia and INDIANAPOLIS, Jan. 20, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug E... |
| Dec 8, 2025 | RESPIREE SECURES SINGAPORE HSA APPROVAL FOR ITS AI-ENABLED 1BIO™AI SOFTWARE TO SUPPORT ACUTE DETERIORATION DETECTION | SINGAPORE, Dec. 8, 2025 /PRNewswire/ -- AI/ML health-tech startup Respiree has received approval from the Health Sciences Authority (HSA) for its 1Bio™AI-Acute toolbox as a Class B software-as-a-medical device (SaMD). The solution is design... |
| Sep 24, 2025 | Leqembi® approved for the treatment of early Alzheimer’s disease in Australia | Leqembi® approved for the treatment of early Alzheimer’s disease in Australia
Wed, Sep 24, 2025 08:40 CET Report this content
Stockholm, September 24, 2025 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) announced today that the Therapeu... |
| Sep 10, 2025 | Medicilon receives international accreditation again - successfully obtains OECD GLP Certification Certificate | Recently, Medicilon officially obtained the Good Laboratory Practice (GLP) certification certificate issued by Mexico, a member country of the OECD. In addition, we successfully passed GLP on-site inspections conducted by Hungary.
Following... |
| Aug 1, 2025 | Norgine welcomes PBS listing in Australia of IFINWIL® (eflornithine) for patients with high-risk neuroblastoma (HRNB) | This news is for Australian Media only
Eflornithine is now reimbursed by the government under Australia's Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of eflornithine fo... |
| May 30, 2025 | NEW THERAPY FOR CHILDREN WITH GROWTH HORMONE DEFICIENCY APPROVED IN AUSTRALIA | SKYTROFA® (lonapegsomatropin) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of paediatric growth hormone deficiency.[1]
SINGAPORE, May 30, 2025 /PRNewswire/ -- Independent biopharmaceutical company Specia... |
| May 9, 2025 | Minaris Advanced Therapies: A New Era in Cell Therapy Manufacturing | In the bustling heart of Philadelphia, a new player has emerged in the world of cell therapy. Minaris Advanced Therapies, born from the merger of Minaris Regenerative Medicine and WuXi Advanced Therapies, is poised to redefine the landscape... |
| May 7, 2025 | Minaris Advanced Therapies launches as the leading global partner dedicated to cell therapy development, manufacturing, and testing | New company unveiled at the annual ISCT conference in New Orleans combines two tenured and innovative CDMOs with a testing powerhouse
PHILADELPHIA, May 7, 2025 /PRNewswire/ -- Through strategic acquisitions made by New York–based investment... |
| Apr 18, 2025 | A New Era in Drug Development: The FDA's Shift from Animal Testing to Human-Centric Methods | The landscape of drug development is changing. The U.S. Food and Drug Administration (FDA) has announced a bold move to phase out animal testing for certain drugs, particularly monoclonal antibody therapies. This decision is a significant l... |
| Apr 17, 2025 | Norgine welcomes TGA registration in Australia of IFINWIL® (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB)[1] | IFINWIL®: now TGA registered in Australia
Children diagnosed with neuroblastoma are on average just 2 years old2
The average survival rate of children with HRNB is only 50%2
UXBRIDGE, England, April 17, 2025 /PRNewswire/ -- Norgine is pleas... |
| Feb 21, 2025 | FIRST AND ONLY TREATMENT FOR CHRONIC HYPOPARATHYROIDISM APPROVED IN AUSTRALIA | YORVIPATH® (palopegteriparatide) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of chronic hypoparathyroidism in adults1
First-in-class novel PTH replacement therapy
Australia becomes the first country to ... |
| Sep 3, 2024 | Vertica by Ohh-Med Medical Secures First Insurance Reimbursement | And Gains TGA Approval in Australia
TIBERIAS, Israel, Sept. 3, 2024 /PRNewswire/ -- Ohh-Med Medical, a pioneer in the rapidly expanding field of interventional urology and men's health, continues to make significant strides in the market wi... |
| Aug 7, 2024 | БАДы из-за которых попадают в больницу | Дисклеймер: ни к чему не призываю, и даже наоборот, освещаю проблему использования конкретных БАДов. Разбираются именно действующие вещества, а не бренды. Более того, как вы могли заметить, я сторонник ноотропной тематики и сам активно прин... |
| Jul 18, 2024 | Telix Pharmaceuticals Q2 2024 Revenue and Business Highlights, Guidance Upgrade | MELBOURNE, Australia, July 18, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on its revenue and operational performance for the quarter ended 30 June 2024 (Q2 2024).
Q2 2024 Finan... |
| Jul 11, 2024 | Telix Welcomes CMS Proposal to Improve Payment for Specialised Diagnostic Radiopharmaceuticals | MELBOURNE, Australia, July 11, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today welcomes proposed changes announced by the Centers for Medicare & Medicaid Services (CMS) for the Hospital Outpatient... |
| Jun 17, 2024 | Оземпик — как препарат от диабета стал средством для похудения? | Представьте, что у вас появилась волшебная таблетка, которая поможет вам за быстрое время сбросить вес. Но есть загвоздка - это препарат, который используется для лечения диабета 2 типа, а ещё он стоит, как чугунный мост.
На связи RISE: Соо... |
| Jun 3, 2024 | Optimi Health Awarded Drug Establishment Licence From Health Canada | VANCOUVER, BC, June 3, 2024 /PRNewswire/ -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a leading Health Canada-licensed psychedelics pharmaceutical manufacturer specializing in... |
| May 31, 2024 | Telix Announces Positive rPFS Data from ProstACT SELECT Trial of TLX591 rADC Therapy Candidate in Prostate Cancer | TLX591 is an investigational anti-PSMA[1] radio-antibody-drug conjugate (rADC) therapy being developed for the treatment of mCRPC, differentiated by a short two-week dosing regimen.
Reported median radiographic progression-free survival (rP... |
| May 21, 2024 | Telix Completes Proof-of-Concept Study of TLX592 Targeted Alpha Therapy in Prostate Cancer | CUPID is a Phase I safety and dosimetry study of TLX592, Telix's investigational antibody-based targeted alpha therapy for prostate cancer.
Establishes proof-of-concept for Telix's proprietary RADmAb® engineered antibody platform, currently... |
| May 4, 2024 | VYNDAMAX® (tafamidis) PBS-listed for adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) with New York Heart Association (NYHA) Class I-II heart failure | VYNDAMAX has been listed on the Pharmaceutical Benefits Scheme (PBS) for adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) with New York Heart Association (NYHA) Class I-II heart failure.[1]
ATTR-CM ... |
| Nov 9, 2023 | Australian Woman's Tragic Death Linked to Popular Weight Loss Drug Ozempic | John Lopez, Tech Times 09 November 2023, 12:11 pm
Multiple reports tell us that the untimely death of 56-year-old Australian woman Trish Webster has been linked to the widely popular weight loss drug Ozempic.
News.com.au reports that Trish'... |
| Jul 11, 2023 | Idefirix (imlifidase) receives provisional approval in Australia as desensitization treatment in highly sensitized patients prior to kidney transplantation | Idefirix (imlifidase) receives provisional approval in Australia as desensitization treatment in highly sensitized patients prior to kidney transplantation
Tue, Jul 11, 2023 12:00 CET Report this content
Regulatory milestone marks the first... |
| Apr 18, 2023 | Social media is fueling enthusiasm for new weight loss drugs. Are regulators watching? | Suzette Zuena is her own best advertisement for weight loss.
Zuena, the "founder/visionary" of LH Spa & Rejuvenation in Livingston and Madison, New Jersey, has dropped 30 pounds. Her husband has lost 42 pounds.
"We go out... |
| Feb 24, 2023 | Study Shows Psychedelics Can Help Longtime Smokers Quit for Years | John Lopez, Tech Times 24 February 2023, 03:02 pm
According to a recent study published in the Kennedy Institute of Ethics Journal, combining psychedelics and talk therapy is an effective method for helping long-term smokers quit.
The study... |
| Feb 6, 2023 | Optimi Health Completes First Production of Novel MDMA Drug Candidate OPTI-MHCL | Full end-to-end, GMP manufacturing of OPTI-MHCL solidifies the Company’s plan to address the global demand for MDMA in 2023 and beyond
The Company is producing OPTI-MHCL in-house under its Health Canada issued Dealers Licence using Optimi’s... |
| Feb 4, 2023 | Australia Now Recognizes Psychedelics MDMA and Psilocybin as Medicines for PTSD and Depression Treatment | John Lopez, Tech Times 04 February 2023, 07:02 am
Australia recently announced the recognition of two powerful psychoactive substances as medicines. Effective July 1, the Therapeutic Goods Administration (TGA) will allow the use of MDMA and... |
| Nov 10, 2022 | A man with ALS who can't use his hands got a brain implant that lets him text, shop online, and play games — just by thinking. It could be a game-changer. | Health A man with ALS who can't use his hands got a brain implant that lets him text, shop online, and play games — just by thinking. It could be a game-changer.
Hilary Brueck
2022-11-10T10:00:00Z
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| Jul 14, 2022 | Vivos Therapeutics Announces Multiple Regulatory Clearances in Australia for Its Entire Line of Oral Appliances | These recent clearances provide further validation to our technology and extend the scope of our international market.
LITTLETON, Colo. (PRWEB) July 14, 2022
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is pleased to announce that it has receive... |
| Jun 1, 2022 | TikTok trend of using essential diabetes drug for weight loss sparks shortage for people who need it | Health TikTok trend of using essential diabetes drug for weight loss sparks shortage for people who need it
Gabby Landsverk
2022-06-01T17:10:35Z
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| May 30, 2022 | Aussie startup champions liquid alternative to powdered baby formula, as shortages strike the US | Even as an Australian company comes to the aid of US parents struggling to procure baby formula for their children, another local founder says a similar shortage could happen in Australia if there is contamination.
Bottle of Nutrition found... |
| Feb 10, 2022 | 15 things not to do when using a rapid antigen test, number 11 will surprise you | Many of us have taken a rapid antigen test (RAT) or have administered them to our school-aged children. But how many of us are using them correctly? asks Thea van de Mortel, professor of nursing and midwifery, Griffith University. Here are ... |
| Jan 21, 2022 | New Coalition Seeks To Reschedule ‘Magic Mushrooms’ Under International Law | A new global coalition is looking to remove international restrictions on the research and medical use of psilocybin, the active ingredient in “magic mushrooms.” |
| Jan 19, 2022 | Time to upgrade from cloth and surgical masks to respirators? Your questions answered | By Leyla Asadi, University of Alberta; C Raina MacIntyre, UNSW; Lisa M Brosseau, University of Minnesota, and Trish Greenhalgh, University of Oxford
With the rapid spread of Omicron, many countries are rethinking their COVID mask advice for... |
| Jan 17, 2022 | The ACCC says it has ‘significant concerns’ about the pricing of rapid antigen tests, as it receives over 150 reports of price gouging from the public a day | The ACCC is investigating retailers charging ‘outrageous’ prices for rapid antigen tests, amid a country-wide shortage.
The ACCC has launched a series of investigations into the exorbitant price of rapid antigen tests.
It follows the consum... |
| Jan 14, 2022 | ВОЗ одобрила два препарата для лечения коронавирусной инфекции — барицитиниб и сотровимаб | Всемирная организация здравоохранения (ВОЗ) опубликовала отчёт, в котором порекомендовала два новых препарата для лечения коронавирусной инфекции — барицитиниб и сотровимаб. В ходе изучения кандидатов организация также рассматривала препара... |
| Oct 22, 2021 | Qantas returns to SA in January, flying from Joburg to Sydney – 3 months ahead of schedule | (Getty Images)
Qantas flights between Johannesburg and Sydney will resume on 5 January 2022.
By that time, Australia’s flag carrier would’ve been missing from South African airspace for almost two years, save for some repatriation flights.
... |
| Sep 13, 2021 | US hospital gets permission to stop prescribing ivermectin for Covid, reversing lawsuit forcing its hand | This picture shows the tablets of Ivermectin drugs in Tehatta, West Benga, India on 19 May on 2021.
Soumyabrata Roy/NurPhoto via Getty Images
An Ohio hospital was sued to force it to prescribe ivermectin for a Covid-19 patient in the ICU.
B... |
| Sep 11, 2021 | Hospital gets permission to cease prescribing ivermectin for COVID-19, reversing a lawsuit that forced it to administer the anti-parasitic drug | This picture shows the tablets of Ivermectin drugs in Tehatta, West Benga, India on 19 May on 2021. Soumyabrata Roy/NurPhoto via Getty Images
An Ohio hospital was sued to force it to prescribe ivermectin for a COVID-19 patient in the ICU.
B... |
| Aug 30, 2021 | RLS Global : ChloraSolv is regulatory approved for diabetic foot ulcers in New Zealand | RLS Global has received regulatory approval for ChloraSolv for treatment of diabetic foot ulcers in New Zealand. With this approval, RLS has established a first market presence in Oceania. The next step will be to broaden the indication in ... |
| Aug 30, 2021 | ChloraSolv is regulatory approved for diabetic foot ulcers in New Zealand | ChloraSolv is regulatory approved for diabetic foot ulcers in New Zealand Mon, Aug 30, 2021 08:00 CET
RLS Global has received regulatory approval for ChloraSolv for treatment of diabetic foot ulcers in New Zealand. With this approval, RLS h... |
| Aug 20, 2021 | Covid-19 roundup: US investigating more myocarditis cases linked to Moderna vaccine; UK approves Regeneron mAb | The Washington Post reported late last night that CDC and FDA officials are investigating where there might be a higher risk of myocarditis, a type of heart condition, in younger adults than previously believed for those ... |
| Jun 23, 2021 | Pharmacovigilance Inspection Program metrics report: Jan - Dec 2020 | Summary
From 1 January 2020 to 31 December 2020, the Therapeutic Goods Administration (TGA) conducted a total of six pharmacovigilance inspections of Australian medicine sponsors as part of its Pharmacovigilance Inspection Program (PVIP). F... |
| Jun 1, 2021 | Australia's original prolonged-release melatonin now available over the counter at pharmacies | MAIN POINTS
Circadin® prolonged-release melatonin is now available without prescription1
Circadin® is clinically proven in people aged 55 and over2 to help them fall asleep quicker, sleep better, wake refreshed, and in turn improve quality ... |
| May 24, 2021 | TGA Therapeutic Goods Administration : approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine | On Monday 24 May 2021, the TGA approved an application from Pfizer Australia Pty Ltd to change its current storage conditions for its COVID-19 vaccine, COMIRNATYTM. The TGA received the application on Thursday May 20, 2021.
This change exte... |
| Feb 27, 2020 | For medicine regulators, reliance is a global imperative | It’s never been more challenging to make sure that medicines meet standards for quality, safety, and effectiveness. Rapidly evolving technologies, advances in medical therapies, and increasingly complex supply chains are stressing medicine ... |
| Nov 13, 2019 | FDA’s Project Orbis may expand to Singapore and Switzerland | The FDA may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore and Switzerland, Richard Pazdur, director of the FDA’s Oncolo... |
| Oct 3, 2019 | Australia suspends sales of certain textured breast implants | Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma.
The Australian Therapeutic Goods ... |
| Sep 18, 2019 | Merck, Eisai cancer drugs win approval in three countries under new regulatory initiative | The approval was granted under Project Orbis, whereby all three regulatory agencies collaboratively reviewed the Merck-Eisai application, exchanging their respective labeling for the combination to learn about any potential differences, tho... |
| Jul 19, 2019 | Therapeutic Goods Admin issues security guidance for medical devices | Australia’s Therapeutic Goods Administration (TGA) has published new guidelines for the security of medical devices and in vitro diagnostic (IVD) medical equipment.
Revealed on 18 July here, the new guidance comes in one version for Guidanc... |
| Oct 11, 2018 | TGA to update regulation for health apps | The Therapeutic Goods Administration (TGA) will update regulations for “software as a medical device” – including health apps - and embark on additional internal software development work in the coming year.
The Administration’s newly-publi... |
| Dec 11, 2017 | Why We Made a Doco About Australia's Medical Weed Outlaws | This article explains our frustrations with Australia's cannabis laws. These frustrations prompted our latest documentary, Stealthcare, but here we'll examine current regulation in more detail.
In February 2016, when the Australian Governme... |
| Aug 27, 2014 | Australian TGA taking a more discerning approach to notified bodies | By Stewart Eisenhart, Emergo Group
The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessm... |
| Aug 22, 2014 | Australian TGA taking a more discerning approach to notified bodies | By Stewart Eisenhart, Emergo Group
The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessm... |
| Apr 14, 2014 | Diabetes: New warnings for Medtronic’s Paradigm insulin pumps | Australian healthcare regulators issued renewed warnings to patients using Medtronic’s (NYSE:MDT) Paradigm insulin pumps, cautioning that an accidental button-press may result in a potentially dangerous overdose.
The Paradigm pumps, which d... |
| Jan 24, 2014 | Clarified reclassification rules from TGA for implantable devices | By Stewart Eisenhart, Emergo Group
Australia’s Therapeutic Goods Administration (TGA) will allow registered manufacturers of partial knee, hip and shoulder implants to submit summary technical reports as part of their reclassification appli... |
| Oct 24, 2013 | Single QMS audit program pilot for medical devices set for January 2014 | By Stewart Eisenhart, Emergo Group
Medical device market regulators in Australia, Brazil, Canada and the US are preparing to launch a pilot for their Medical Device Single Audit Program (MDSAP) in January 2014.
Participating regulators – th... |
| Oct 7, 2013 | Changes to Australia’s radiofrequency spectrum could affect medical devices | Australia’s Therapeutic Goods Administration is advising that upcoming changes to to radiofrequency spectra Down Under could affect "a small number" of medical devices.
The TGA said the changes, planned for next month, are being m... |
| Sep 23, 2013 | Australian regulator issues guidance on mobile medical apps | By Stewart Eisenhart, Emergo Group
Australia’s medical device market regulator, the Therapeutic Goods Administration (TGA), has published guidance on its approach to medical software and mobile medical applications.
Based on the TGA guidanc... |
| Sep 19, 2013 | More fall concerns for large imaging systems as Philips issues warning | Technology giant Philips (NYSE:PHG) issued a warning on its BrightView XCT diagnostic imaging systems after a patient and a technician were hit by a falling component.
The technician had been attempting to maneuver the "flat panel dete... |
| Aug 14, 2013 | Diabetes: Aimedics recalls all HypoMon sleep glucose-monitoring devices | Medical device company Aimedics is pulling all units of its HypoMon sleep monitoring device off the shelves in Australia following reports that the device’s alarm does not work as well as stated.
HypoMon is a night-time device for children ... |
| Aug 8, 2013 | Zimmer recalls knee implants over labeling concerns | Orthopedic giant Zimmer (NYSE:ZMH) is pulling components of its NexGen CR Complete Knee Systems off of the Australian market in order to update their labeling in light of some compatibility issues arising among surgeons.
Zimmer in March 201... |
| Aug 7, 2013 | Labeling glitch with Boston Scientific’s Promus Element Plus prompts recall in Australia | Boston Scientific (NYSE:BSX) shipped some of its Promus Element Plus Monorail coronary stents with the wrong labels in Australia, prompting that country’s Therapeutic Goods Administration to issue a recall.
The Promus stents were shipped wi... |
| Jul 23, 2013 | Stryker pulls spinal devices off the shelves following failure reports | Australia sounded the alarm on Stryker’s (NYSE:SYK) Oasys Midline Occipital Plate, sending a warning to patients and surgeons that the spine stabilization device might break after surgery.
Stryker’s spinal stabilization plate is part of the... |
| Jul 16, 2013 | Medtronic recalls implantable pacemakers over manufacturing concerns | Updated July 16, 2013, with information from Medtronic.
Medical device giant Medtronic (NYSE:MDT) is asking hospitals to return certain cardiac resynchronization therapy pacemakers (CRT-Ps) after the company discovered manufacturing issues ... |
| Jun 12, 2013 | Regulators Down Under issue a hazard alert on J&J’s shoulder surgery guides | Australian healthcare regulators this month issued a hazard alert on a single lot of Johnson & Johnson’s (NYSE:JNJ) surgical assist devices after it was discovered that the orientation guides had arrows on the wrong side, possibly leadi... |
| May 16, 2013 | Australian regulators propose changes to IVD oversight plan | By Stewart Eisenhart, Emergo Group
Australia’s Therapeutic Goods Administration (TGA) has published proposed changes to upcoming in vitro diagnostic (IVD) regulations for comment ahead of a proposed final implementation date of July 2014.
H... |
| May 13, 2013 | Another recall for Johnson & Johnson Down Under | Another Johnson & Johnson (NYSE:JNJ) product is the subject of a recall, this time from the Australian Therapeutic Goods Administration
Some of J&J subsidiary Ethicon Endo-Surgery’s Ligaclip devices are being pulled from hospital sh... |
| Apr 12, 2013 | Alcon Labs issues hazard alert on certain intraocular lenses | Alcon Laboratories in conjunction with Australian healthcare regulators issued a warning on certain intraocular lenses after receiving reports of higher-than-expected rates of accelerated endothelial cell loss.
Alcon warned that a 5-year st... |
| Apr 11, 2013 | Aussie health regulators issue 3 warnings on Medtronic insulin pumps| MassDevice.com On Call | MASSDEVICE ON CALL — Healthcare regulators down under issues a safety advisory for a trio of potential problems with certain Medtronic’s (NYSE:MDT) Paradigm insulin pumps.
The Australian Therapeutics Goods Admin. warned patients of 3 issues... |
| Apr 3, 2013 | Diabetes: J&J recalls OneTouch Verio IQ glucose meters over failure to warn at extreme levels | Healthcare giant Johnson & Johnson (NYSE:JNJ) recalled all lots of its Verio IQ glucose meters over concerns that the device will fail to warn a diabetic patient in the extremely rare case of a blood glucose level higher than 56.8 mmol/... |
| Apr 3, 2013 | Australia issues warning on American Medical Systems’ urinary control systems | Australian healthcare regulators issued a safety advisory late last month on certain lots of American Medical Systems’ AMS 800 urinary control systems, warning that the devices were released on the market on the market without meeting the c... |
| Feb 20, 2013 | Stryker recommends more vigilant monitoring of patients with recalled hip implants | Stryker’s (NYSE:SYK) Australian arm provided national health regulators with updated recommendations for monitoring patients who received the company’s now-recalled ABG II Modular hip systems.
Australia’s Therapeutic Goods Admin. issued the... |
| Nov 1, 2012 | Zimmer pulls metal-on-metal Durom acetabular hip implants from Australian market | In another blow to the metal-on-metal hip implant market, orthopedic giant Zimmer Holdings (NYSE:ZMH) canceled its Durom Acetabular Component from the Australian Register of Therapeutic Goods, the regulatory agency announced this week.
The ... |
| Feb 17, 2011 | Australia releases regulatory update for in vitro devices | By Stewart Eisenhart, Emergo Group
The Therapeutic Goods Administration (TGA), Australia’s medical device regulator, has specified which in vitro devices (IVDs) will be required to undergo application audits.
According to Australia’s Therap... |
| Merck, Eisai cancer drugs win approval in three countries under new regulatory initiative | A combination of two drugs in endometrial cancer is the first to win approval under a new initiative by international regulatory agencies designed to speed up approvals of cancer drugs.
On Tuesday, the U.S. Food and Drug Administration, Hea... |
| Sex, lies and discounts: The shady marketing tactics used to sell vapes online | Source: Unsplash/Chiara Summer
It’s easy to buy vapes or e-cigarettes online. When we looked at websites selling them to buyers in Australia and New Zealand, we found a variety of slick, false, or misleading marketing claims.
In our new res... |
