MELBOURNE, Australia – Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies so that patients can access them.
The U.S. FDA's breakthrough devices program continues to rack up new designations, this latest one for Shréis Scalene Sciences LLC's Cytotron device. The noninvasive whole-body system, which is intended to break down or interrupt the growth of malignant tumors, is already CE marked and available in the European Union.
The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated.
Robotics has been a hot topic over the last year or so, from product unveilings to M&A. Now, Xact Robotics Ltd., which has a presence in Hingham, Mass., and Caesarea, Israel, has reported that its first robotic system gained clearance in the U.S. for use during computed tomography-guided percutaneous interventional procedures.
Shares of Agile Therapeutics Inc. (NASDAQ:AGRX) trebled Thursday, rising 223.8% to $1.20 at the market's close following a near-unanimous FDA adcom vote the day before supporting approval for the company's transdermal contraceptive patch, Twirla (levonorgestrel/ethinyl estradiol).
HONG KONG – Indonesian regulators have introduced a medical device risk classification system, as part of a harmonization of regulations across the Association of Southeast Asian Nations (ASEAN) region. The 'Sistem Klasifikasi Risiko Alat Kesehatan' system, known by the acronym Siklara, takes its cues from the ASEAN Medical Device Directive (AMDD).
The U.S. FDA's overhaul of the 510(k) program continues apace with the recent final guidance for the special 510(k) mechanism. However, a member of the FDA staff said clerical errors account for a conspicuous number of conversions of these applications to traditional 510(k)s than any other problem. The agency posted the final guidance for the special 510(k) program in September with features seen in the draft that drew opposition from device makers.
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