Medtronic plc has won the U.S. FDA’s nod for the first deep brain stimulation (DBS) system that integrates Brainsense, the company’s technology to sense and record brain signals for more personalized treatment. The next-generation Percept PC DBS with Brainsense is approved to treat symptoms associated with Parkinson’s disease, essential tremor, dystonia, epilepsy and obsessive-compulsive disorder. Read More
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year. Read More
Startup Brightinsight Inc. is working to make the infrastructure behind digital health easily accessible to pharma and med-tech companies. To aid it on this path, the San Jose, Calif.-based company has raised a $40 million series B round to expand its capabilities and global reach. Read More
Ekso Bionics Holdings Inc. has received a green light from the U.S. FDA to market its Eksonr robotic exoskeleton for use with patients with acquired brain injury (ABI). The company said it is the first exoskeleton product to receive the agency's nod for rehabilitation use with ABI, allowing a broader patient population to access the device. This is good news for Richmond, Calif.-based Ekso, which, like many other device companies, saw its earnings off during the first quarter. Read More
Hong Kong – Vuno Inc. is looking to access more markets after inking a partnership with Japan’s M3 on June 19. The partnership with M3, a medical data platform which is 34% owned by conglomerate Sony Corp., allows Vuno to tap into the Japanese market. The M3-Vuno tie-up aims to encompass all Vuno’s existing products. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Dayzz, Elixir Medical, InspireMD, Medtronic, Sintx Technologies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1Health.io, Cylera, Dentsply Sirona, Ebb Therapeutics, Edge Endo, Global Wholehealth Partners, Hamilton Health, Hi-Clearance, Joimax, Labcorp, Neovasc, Pharmaceutical Product Development, Pri·Med Medical Products, Royal Philips, Physiq, Sequana Medical, Sleepscore Labs, Stevanato Group, The Abedgraham Group, US Endodontics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Babson Diagnostics, Circadia Health, Ekso Bionics, Medtronic, Nyxoah, Viraxclear. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ACLA, Novartis, Regeneron, Willow Labs. Read More
Keeping you up to date on recent developments in diagnostics, including: Border detection algorithm for melanoma; Predicting future suicide risk; Multiracial study gives new diabetes insights; Patient genetic variants linked to wound microbiomes. Read More
