Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February.
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.
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.
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).
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%.
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.