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BioWorld - Tuesday, May 26, 2026
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U.S. White House

Device tax falls as Trump signs FY 2020 spending bills

Dec. 23, 2019
By Mark McCarty
The much-maligned medical device tax was finally laid to rest Dec. 20, as President Donald Trump signed a spending bill that included a permanent repeal of the tax. The 2.3% excise tax on devices was brought into the statute via the Affordable Care Act (ACA), and its repeal brings much-needed breathing room to small device makers.
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FDA approves Enhertu for unresectable or metastatic HER2-positive breast cancer

Dec. 23, 2019

Orkedia approved in Japan for hypercalcemia in parathyroid carcinoma or primary hyperparathyroidism

Dec. 23, 2019

FDA approves Dayvigo for insomnia

Dec. 23, 2019

Ryaltris receives marketing approval in Australia

Dec. 23, 2019

Regulatory front for Dec. 20, 2019

Dec. 20, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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FDA sign

FDA says cranial electrotherapy devices are class III for depression

Dec. 20, 2019
By Mark McCarty
Seven years after an advisory hearing on the subject, the FDA has determined that cranial electrotherapy stimulation (CES) devices will be slotted as class III devices when used for depression. The decision comes despite a number of irregularities that took place at the February 2012 advisory hearing.
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CMS OKs coverage for Pq Bypass TORUS 2 study

Dec. 20, 2019
By Meg Bryant
Pq Bypass Inc., of Milpitas, Calif., said that the Centers for Medicare and Medicaid Services (CMS) has agreed to cover its TORUS 2 investigational device exemption (IDE) clinical trial, which is evaluating the Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).
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Ebola virus vaccine vial and syringe

FDA’s approval of Ebola vaccine will be felt around the world

Dec. 20, 2019
By Lee Landenberger
While Ebola virus disease in the U.S. is a rare occurrence, the FDA approval of Merck & Co. Inc.’s Ervebo, the agency’s first for preventing Ebola Zaire virus in people age 18 and older, will have a ripple effect across the world, especially Africa where its effects have been devastating for decades. Stockpiling such a vaccine is crucial to world safety as Ebola has long been a potential bioterrorism threat, especially after 9/11. In the world of theoretical biological warfare, where the virus could be weaponized and disseminated by aerosol, Ebola virus is considered the most dangerous, with fatality rates estimated between 25% to 90%.
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etectRx-ID-Capsule-12-19.png

Ingestible medication tracking gets second entrant with FDA nod for Etectrx

Dec. 20, 2019
By Stacy Lawrence
Gainesville, Fla.-based startup Etectrx Inc. has secured an FDA clearance for its ingestible event marker system, the ID-Cap system. The startup is following in the footsteps of Redwood City, Calif.-based Proteus Digital Health Inc., which pioneered the category.
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