Two studies presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference directly compared Boston Scientific Corp.’s Watchman 2.5 and Watchman Flx to Abbott Laboratories’ Amplatzer Amulet device. Both showed Amulet had less than half as many leaks, but the clinical impact of the lower rate remained unclear.
Catheter-based delivery of replacement valves is established practice for patients with aortic regurgitation, but the mitral valve has only repair devices to address this condition. However, transcatheter mitral valve replacement (TMVR) devices by Dublin-based Medtronic plc., and triscupid valve replacement devices by Edwards Lifesciences Inc. of Irvine, Calif., made some noise at this year’s edition of Transcatheter Cardiovascular Therapeutics (TCT), suggesting that these patients might soon have a wider range of options.
Alcon AG plans to acquire Ivantis Inc. for $475 million at closing, regaining a significant position in the lucrative minimally invasive glaucoma surgery (MIGS) space through the addition of the Hydrus microstent device to its ophthalmology portfolio. In addition to the up-front payment, the deal includes additional unspecified contingent payments dependent on achievement of certain milestones. The transaction is expected to close in the first quarter of 2022.
Shares in Rewalk Robotics Ltd. are on the rise after the FDA awarded its Reboot exoskeleton device breakthrough device designation status. The wearable, battery-powered device is designed to assist individuals with lower limb disability due to stroke.
The U.K. National Institute for Health and Care Excellence said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp. (BSX), are ready for prime time in the U.K. national health system.
In an effort to advance a fiscal 2022 spending package through a divided Congress, U.S. President Joe Biden released the framework for his Build Back Better agenda Oct. 28 – minus provisions that would allow Medicare to directly negotiate at least some prescription drug prices.
Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices.
As the U.S. House of Representatives resumes work Aug. 23 on a budget reconciliation proposal to get a $3.5 trillion fiscal 2022 budget across the finish line, many lawmakers are looking to provisions to reduce prescription drug prices as a way to pay for increased spending in other health care sectors.
The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. Virpax is in a crowded field of 43 COVID-19 intranasal therapeutics and vaccine programs.
PERTH, Australia – The Treasury Department is seeking feedback from industry stakeholders on its discussion paper on a patent box policy, which was first announced in the May 2021 federal budget.
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