Adaptive Biotechnologies Corp. posted revenue of $30.2 million for the fourth quarter of 2020, up 25% from the corresponding prior year period. The tally beat consensus by $3.3 million. Clinical sequencing volume grew 41% to 4,539 clinical tests, compared with the fourth quarter of 2019. For the full year, revenue increased 16% year over year to $98.4 million, and clinical sequencing volume topped out at 15,216 clinical tests delivered, up 50%. The results coincided with the launch of the company’s T-Detect COVID, the first clinical T cell-based test to confirm recent or prior COVID-19 infection. Read More
If Marvel’s Peter Parker had chosen to apply his graduate work in biochemistry and his web-shooters to medicine, he might have created something like Nanomedic Technologies Ltd.’s Spincare system. The system uses a hand-held medical gun that prints a flexible, transparent layer of artificial skin directly on a wound or burn. The Electrospun Healing Fiber (EHF) technology creates a waterproof, protective nano polymer matrix. Read More
Test developers and the U.S. FDA are scrambling to meet the testing needs of the American public, however, it's somewhat unclear what the agency's priorities are for the emergency use authorization (EUA) program. Jeffrey Shapiro, of Hyman Phelps & McNamara, made the case that the FDA’s Center for Devices and Radiological Health (CDRH) should be more transparent about its priorities for EUA review. Read More
HONG KONG – Wuxi Diagnostic Investment (Cayman) Ltd. has raised $150 million in a series B financing round, while netting a number of new investors along the way. The new investors to come on board include Thermo Fisher Scientific Inc., Shiyu Capital, ABC International Holdings Ltd., Sunland Capital and CCBI Tech Venture. Read More
Withings Health Solutions, the business-to-business division of the connected health company Withings SA, is launching two cellular-connected devices that allow patients to measure their weight and blood pressure at home and immediately transmit the results to a health care provider. The products – the Body Pro smart scale and the BPM Connect Pro at-home blood pressure monitor(BPM) – are being marketed directly to health professionals, as well as researchers and chronic disease management companies, for distribution to patients to use at home. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Cryostem, Assure Holdings, Biotherapeutic Labs, Bird & Cronin, Caredx, Cerus, Charles River Laboratories, Clinical Reference Laboratory, Co-Diagnostics, Collplant Biotechnologies, Dynatronics, Grin, Henry Schein, Icon, Illumina, Imaging Endpoints, Intalere, Kibur Medical, Neovasc, New England Biolabs, Oxford Nanopore Technologies, Patientslikeme, PRA Health Sciences, Protembis, Puretech Health, Renalytix AI, Rubiconmd, Sentry Neuromonitoring, Shandong Zhongbaokang Medical Implements, Siren Care, Smiledirectclub, SQN Clinical, Transchart, TX Services, United Therapeutics, Veristat, Walgreens. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobarica, Debx Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MHRA lists premarket requirements; OIG says up-coding may be driving more expensive admissions; TGA tees up Haimex; White House calls for 100-day review for supply chain. Read More
Keeping you up to date on recent developments in diagnostics, including: Atherosclerosis precedes clonal hematopoiesis; AI-driven tool to assess kidney function; Deep learning-powered classification of lung cancer types. Read More
