Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache. Read More
The impetus to provide more Medicare coverage of telehealth may prove irresistible, but the Medicare Payment Advisory Commission (MedPAC) has some reservations, including that telehealth payment rates should not favor companies like Dallas-based Teladoc Health Inc. over bricks-and-mortar clinics. This and other considerations are driving the commission toward a recommendation that a two-year telehealth pilot program would be more appropriate than simply jumping into a quickly broadened world of Medicare telehealth coverage. Read More
Driving to a laboratory for blood testing may soon be a thing of the past. Babson Diagnostics Inc. just completed a pivotal study of its new system for collecting and analyzing blood from a finger prick at a pharmacy counter. The results indicate that the microsample system provides comparable results to phlebotomist-drawn venipuncture blood samples. Read More
TORONTO – Pointclickcare Technologies Inc. has followed up a series of private sector investments and purchases with its acquisition of Collective Medical Inc. and its real‐time notification platform for streamlining transitions from one stage of health care to another and reducing unnecessary length of stay and patient admissions. One of this country’s largest software companies, Pointclickcare said the US$500 million plus acquisition will pair its “rich, post‐acute data set” with Collective Medical’s network of more than 1,300 hospitals and other health care organizations across 39 states. Read More
Brain Scientific Inc., a neurology-focused device and software company, is seeking to combine a miniaturized electroencephalogram (EEG) with subcutaneous graphene electrodes to produce a minimally invasive brain monitoring device that could provide continuous data on patients with neurological conditions. The device, which the New York-based company is calling the Brain E-Tattoo, would monitor brain wave activity outside the clinical setting, allowing for long-term continuous data collection without interrupting daily life. Read More
LONDON – There is “a realistic possibility” that infection with the B 1.1.7 variant of SARS-CoV-2 is associated with a 30% to 40% increased risk of death compared to earlier variants of the virus, according to scientists on the U.K. government’s New and Emerging Respiratory Virus Threats Advisory Group. That conclusion is based on studies by three university groups, linking community PCR testing to mortality. Read More
New hires and promotions in the med-tech industry, including: Amd Medicom, Harvard Medtech, Mainstay Medical, Maverick Medical AI, Second Genome, Vericel. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Artificial, Brainsway, Emed, Flurotech, Gaelan, Medtechnica, Nanocomposix, Renalsense, Roche, Sysmex, Therapeutic Solutions International, Thermo Fisher Scientific, Volitionrx. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerobiotix, Choicespine, Orthospin, Pedra Technology, Theranica. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Telehealth bill resurfaces in 117th Congress; OIG includes telehealth in FY 2021 workplan. Read More
Keeping you up to date on recent developments in cardiology, including: Age influences sex-related outcomes following a heart attack; Fried food intake fingered in upped risk of heart disease, stroke; Genetic risk factor for stroke revealed. Read More
