The digital therapeutics market has seen an explosion of innovative products and interested investors. Regulators, too, have acknowledged their potential to improve outcomes in patients with chronic or debilitating conditions – often at lower cost and with less side effects than traditional drug therapies. To that end, the FDA has granted breakthrough device designation to Swing Therapeutics Inc. for its prescription digital therapeutic for the management of fibromyalgia. Read More
Auctus Surgical Inc. took another step toward straightening out one of the most vexing problems in pediatric scoliosis with the announcement of FDA breakthrough device designation for its vertebral tethering system. The system offers a non-surgical option to correct spinal curvature without use of fusion or braces and its dynamic magnetic technology enables adjustment as a child grows, avoiding the overcorrection that plagues the only other tethering system currently available. Read More
The FDA’s latest version of the intended use rule is a complex, 61-page document that cleaned up a few things from the previous version and added a phrase or two to the regulatory lexicon. Randy Prebula, a partner in the D.C. office of Hogan Lovells U.S. LLP, told BioWorld that while the FDA left itself some wiggle room by avoiding a prescriptive use of language in the rule, the final rule is unlikely to be the final word on the intended use question. Read More
Pulse Medical Imaging Technology (Shanghai) Co. Ltd. has raised more than $100 million in a series C funding round to accelerate the R&D, clinical trials and commercialization of its products. “Pulse plans to use the funds to accelerate the commercialization of its fractional flow reserve (FFR) estimating systems,” Xiaojie Lin, marketing director of Pulse, told BioWorld. FFR is a method to measure blood pressure and flow within a coronary artery to check on the possibility that the stenosis impedes oxygen delivery to the heart muscle. Read More
A total of 946 med-tech deals so far in 2021 are valued at $537.42 million, which pales in comparison to each of the last three years, although the volume is way ahead, indicating robust activity but a high number of deals with undisclosed terms. Read More
The FDA’s device center has generated a raft of warning letters for products related to the COVID-19 pandemic, and released another six such letters for the week of Aug. 9. However, the ostensible justification for those warnings varies considerably, as does the elapsed time between the date of the warning letter and its issuance on the FDA’s warning letter webpage. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biostrap, Ethicon, Humacyte, Lucia Health Guidelines, Personal Genome Diagnostics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Alverno Laboratories, Augmedix, Avera Health, Curebase, Ibex Medical Analytics, Lifeworks, Microsoft, Samsung, Second Sight, TDC Group. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3NT Medical, Able Medical Devices, Acutus Medical, Auctus Surgical, Boston Scientific, Swing Therapeutics. Read More
