Some U.S. FDA warning letters are mostly about documentation, but the key consideration in the widely publicized Dec. 9 FDA warning letter to Dublin-based Medtronic plc seems to be whether Medtronic had a proper understanding of the risk created by malfunctioning infusion pump retainer rings. That difference of opinion regarding risk took a significant bite out of the company’s shares and boosted the fortunes of its rivals in the diabetes space, a cautionary tale regarding the hazards associated with a failure to understand how the FDA sees the risk of device malfunction. The FDA had reported in October 2021 a pair of recalls of Medtronic’s Minimed insulin pumps, although one of the issues cited was related to cybersecurity concerns. The two recalls affected nearly half a million units combined, and could have significantly affect access for some patients. Read More

PERTH, Australia – Australian digital health company Resapp Health Ltd. received clearance from Australia’s Therapeutics Good Administration and CE mark certification in the EU for its stand-alone cough counter application that tracks cough frequency using a smartphone. The class I software as a medical device is the first regulatory approval for such an application, which uses Resapp’s machine learning algorithms to identify cough events from audio recorded using the smartphone’s in-built microphone. Read More

With a new CEO at the helm, remote patient monitoring (RPM) company Qardio Inc. believes 2022 can be a pivotal year to drive adoption of its 4G and Bluetooth-enabled cardiac solutions. The San Francisco-based company recently launched Qardiocore, an ambulatory ECG, and Qardiodirect, an end-to-end remote patient monitoring and telehealth service. Read More

In a move that will substantially expand the number of livers available for transplantation, the FDA granted premarket approval to Organox Ltd.’s Metra normothermic machine perfusion device for both donors after brain death (DBD) and donors after circulatory death (DCD). The approval allows preservation of organs by Metra for up to 12 hours. Read More

It is acknowledged that the huge bias toward individuals of European ancestry means studies of the contribution of genetics to disease may not translate well to other ethnicities. That point is underlined in the first large-scale investigation of the population structure and demographic history of British Pakistanis, which shows an increased number and length of regions of homozygosity inherited from a common ancestor, and greatly elevated identity by descent, compared to the population at large. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Co-Defend, Co-Protect, Lucira, Pacbio, Seegene. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Paragon 28. Read More