Digital health has made only limited headway in the orthopedics space, but Zimmer Biome Inc. and Canary Medical Inc. have nudged the cause along with a smart implant that blends a 21st century sensor with a traditional knee replacement device. The marriage of Zimmer’s Persona knee implant and the Canary Medical Canturio TE sensor will give physicians a better way to track the patient’s recovery from knee replacement procedures. Read More
Genome Medical Holding Co. put its competitors on notice with two big moves designed to position the company as a leader in genetic testing and virtual genomic care. The company acquired Genematters LLC, a provider of telegenetics counseling, and closed a $60 million series C fundraising round. Together, the moves stand to significantly expand Genome Medical’s digital infrastructure and clinical expertise in genetics services. Read More
China’s ongoing efforts to tighten regulations across the board is hitting medical device companies. Two companies that issued shares in Hong Kong for the first time over the past week saw their shares tumble right out of the gate. Acotec Scientific Holdings Ltd. (HK: 6669) shares fell more than 25% on their first trading day on the Hong Kong Stock Exchange on Aug. 24 amid regulatory changes in China’s health care industry. Read More
PARIS – Researchers from the department of radiation oncology at the European Hospital Georges Pompidou (HEGP) and Stanford University School of Medicine have together developed a new artificial intelligence (AI) prediction tool for patients diagnosed with prostate cancer. These researchers have just published a validation of this interpretable AI model in Cancers. “It’s a question of distinguishing patients at risk of mortality from aggressive cancer that is spreading rapidly, from patients who might have far less aggressive cancer and who are not likely to die from it in under 10, 15 or even 20 years,” Jean-Emmanuel Bibault, radiotherapy oncologist at HEGP, told BioWorld. Read More
The FDA has released two draft guidances under the safety and performance-based pathway for class II devices, proving some much-needed momentum for the agency’s fiscal year 2021 guidance agenda. The two drafts address performance metrics for facet screw systems and the use of resins in dentures, thus adding substantially to the number of class device types that can be reviewed outside the usual substantial equivalence mechanism ordinarily relied upon in the 510(k) program. The FDA began implementing the safety and performance-based pathway for devices in late 2019, an approach that serves as a substitute for the abbreviated 510(k) mechanism. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioventus, Cartiheal, Microport, Stereotaxis. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Impedimed, Phase Scientific, Vapotherm, Visby Medical. Read More
