Movendo Technology srl and Maragal Medical PC have collaborated to provide free community screening for the risk of falls for Massachusetts Medicare patients using Movendo’s Hunova robotic technology. Hunova performs a progressive assessment on seated and standing patients to evaluate their flexibility, strength and balance. The system also provides personalized rehabilitative therapy recommendations. Read More

The U.S. CMS has crafted a payment policy that covers both adjunctive and non-adjunctive continuous glucose monitors (CGMs) in the final rule for durable medical equipment (DME). Medtronic plc, of Dublin, heralded the move as “a very important benefit expansion” for the company’s customers, but the expanded coverage also pays for additional CGMs that work with Medtronic insulin pumps. Read More

India’s Department of Pharmaceuticals (DOD) released draft guidelines to boost research and development in its pharmaceutical and medical device industries. The document touched on the reasons for a dedicated R&D and innovation policy, which involved reducing import dependence, increasing the speed of biologic and biosimilar development cycles, and tackling infrastructural challenges. Read More

The FDA has delivered on a final guidance for non-clinical and clinical investigations of devices used for treatment of benign prostatic hyperplasia (BPH), needing only a year and a half to convert the draft guidance into a final version. The final guidance retains the draft’s recommendation that pivotal studies follow patients for at least a year, a provision some in the med-tech industry saw as unnecessary in some instances. The scope of the July 2020 draft included non-clinical testing, a novelty compared to previous guidance on the topic. The scope of this latest guidance includes four product codes, including KNS for endoscopic electrosurgical instruments, and the FDA included several specific suggestions for the use of thermotherapy and permanent prostatic stents as treatments for BPH. Read More

Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eoflow, Lunit, Sentinel Capital, TTG Imaging, Zihipp. Read More

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