The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.

Developers of apps for digital health have struggled to obtain Medicare coverage in the U.S. for their products, an impasse that seems unlikely to resolve anytime soon. Jason Bennett of CMS said on a Feb. 9 webinar that while the durable medical equipment (DME) benefit category seems like a natural fit for digital health products, there are some statutory and definitional roadblocks, including that digital health products might not be durable enough to qualify.

Second Sight Medical Products Inc. has struck a deal to acquire Nano Precision Medical Inc. (NPM) in an all-stock transaction. NPM will merge with a wholly owned subsidiary of Second Sight, and the combined company will focus on the development of drug and device medical implants. The deal comes less than a year after Second Sight’s proposed acquisition of French company Pixium Vision LLC fell through in controversial fashion. The company will issue approximately 134 million shares of its common stock to acquire full ownership of NPM and shareholders will acquire approximately 23% equity of the combined company

The Cooper Companies Inc. plans to acquire the entirety of Cook Medical Inc.’s reproductive health business in this fiscal quarter for $675 million at closing plus $200 million paid in four $50 million annual installments. The acquisition will expand Cooper’s presence in the Asia-Pacific region. The Cook deal will also accelerate Cooper’s labor and delivery medical device efforts by adding 115 people sales, marketing, education and support staff globally.

While a number of U.S. cities and towns have been conducting wastewater testing for the SARS-CoV-2 virus for some time, the CDC has finally established a dashboard for reporting the results of this surveillance. While the resulting data may be useful in the current pandemic for allocation of resources, the establishment of a network of wastewater surveillance instruments can also be instrumental in future public health efforts, such as tracking foodborne infections and detecting the emergence of new antibiotic-resistant pathogens.

Witnesses at a Feb. 8 hearing in the U.S. Congress emphasized that the proposed Advanced Research Projects Agency – Health (ARPA-H) must be an independent agency to avoid a crippling case of bureaucratic torpor. However, several members of Congress and one of the witnesses made the case that ARPA-H would increase duplicative taxpayer spending without providing a commensurate increase in productive research in the life sciences, signaling that establishment of this new DARPA-like agency is anything but guaranteed.

Know Labs Inc. has received approval from an independent institutional review board for an internal clinical study of its noninvasive glucose monitoring technology. The aim is to further validate the Bio-RFID (radio frequency identification) platform’s ability to accurately measure and detect changes in blood glucose levels. The study will be conducted at the Seattle-based company’s new research and development laboratory and include 200 subjects.

Johnson & Johnson business Cerenovus Inc. is launching a balloon guide catheter for the U.S. and Canada stroke market. The Irvine, Calif.-based company’s Emboguard device is designed to remove blood clots by controlling blood flow during mechanical thrombectomy procedures. It is the latest addition to the Cerenovus stroke portfolio, which includes the Embotrap III revascularization device, the Prowler EX microcatheter, the Cerenovus large bore catheter and Cerebase guide sheath.

The U.S. House of Representatives passed the COMPETES Act of 2022 in a narrow Feb. 4 vote that may help restore U.S. manufacturing of pharmaceuticals and the semiconductors that are critical for medical devices. However, the House bill also includes unrelated provisions such as a section dealing with health insurance costs, just one of several elements that are not seen in a similar Senate bill and which foreshadow a drag-inducing showdown between the two bills.