The U.S. CMS posted the draft Medicare physician fee schedule (MPFS) for calendar year 2023, and advocates of telehealth will be cheered by a proposed extension of some pandemic-driven telehealth services throughout 2023. The draft is less generous in connection with external electrocardiogram patches in a move that could ding Irhythm Technologies Inc., and its Zio XT device, but analysts at BTIG predict that any hit to reimbursement rates is likely to be offset with greater sales volumes, leaving Irhythm and its investors in a solid place going forward. Read More
Rainmed Medical Ltd. raised HK$146 million (US$19 million) in an initial public offering in Hong Kong. Its shares debuted at HK$5.60 and dropped as much as 15.38% to close at HK$5.28 on July 8, 2022, the first trading day. Jiangsu, China-based Rainmed Medical plans to use 80% of the proceeds to support the development and commercialization of its core products – a coronary angiography-derived fractional flow reserve (caFFR) system and a coronary angiography-derived index of microvascular resistance (caIMR) system. Read More
Kranus Health GmbH has raised $6.5 million in series A funding to ramp commercialization of its digital therapy for treating erectile dysfunction (ED). Eleven European investors participated in this fundraising. The round was led by early-stage health care venture capitalists Karista SAS, while Peak Pride Management GmbH also joined the funding round. Read More
The Persona IQ combines a knee implant created by Zimmer Biomet Inc. with sensor technology developed by Canary Medical Inc. to capture performance data on range of motion, walking speed, step count and other orthopedic metrics. Liane Teplitsky, Zimmer Biomet’s president of global robotics likens the Persona IQ to a cardiac pacemaker, in this instance collecting important data on the knee implant so doctors working remotely can better understand how the device is performing post-surgery. Read More
The U.S. FDA’s third-party review program for 510(k) filings has perhaps never quite lived up to expectations that this program would take a significant load off the FDA’s shoulders, and the latest quarterly report does nothing to detract from that perception. Read More
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aethlon Medical, Opsens, Stereotaxis. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelerate Diagnostics, Nyxoah. Read More