Regulation

Hand holding Bigfoot rapid-acting smart insulin pen
By  Mallory Hackett 11:58 am May 10, 2021
This morning, Bigfoot Biomedical announced it has received FDA 510(k) clearance for its Bigfoot Unity Diabetes Management System. The system was cleared for use among individuals 12 years old and up with Type 1 or Type 2 diabetes who use multiple-dose injection therapy. Included in the Bigfoot Unity System are two smartpen caps for both rapid- and long-acting insulin, a connected mobile app, an...
Viome's Health Intelligence kit
By  Mallory Hackett 11:24 am May 7, 2021
Viome, maker of at-home test kits for gut, immune and cellular health, has received FDA breakthrough device designation for its mRNA analysis technology and artificial intelligence platform that detect early signs of oral cancer and throat cancer. The FDA designation validates the technology used in Viome’s at-home Health Intelligence Test that analyzes users’ microbial, human and mitochondrial...
KardiaMobile 6L being used.
By  Mallory Hackett 11:42 am April 22, 2021
Personal electrocardiogram maker AliveCor is seeking to ban U.S. sales of Apple Watches after claims that the tech giant infringed on its patented technology. The company announced this week it has filed a complaint with the U.S. International Trade Commission alleging that Apple breached patent laws on three of AliveCor’s patented devices. AliveCor asserts that Apple knowingly copied its...
Peloton Tread+
By  Laura Lovett 11:40 am April 19, 2021
During the COVID-19 pandemic, Peloton's connected bike and treadmill became the "it" workout devices. Last quarter, the workout giant beat its revenue expectation by more than $34 million. But the company is now on rocky footing. On Saturday, the U.S. Consumer Product Safety Commission issued a warning about the dangers of the Peloton Tread+ after a slew of injuries in small children, including ...
ActivSight device
By  Laura Lovett 02:49 pm April 15, 2021
Last week the FDA gave the green light to Boston-based Activ Surgical's intraoperative imaging module ActivSight, which is aimed at improving surgical visualization. The company has developed a technology that is able to give surgeons real-time intraoperative visual data. ActivSight is a small hardware-agnostic device that connects to an endoscope and a camera system. The system is able to...
Vital sign monitor
By  Mallory Hackett 12:09 pm April 12, 2021
Donisi Health, a Tel Aviv-based maker of contactless health monitoring products, recently announced it has received FDA De Novo clearance for its Gili Pro BioSensor system. The Gili Pro uses a combination of optical sensors and proprietary artificial intelligence algorithms to remotely monitor surface-level micro-vibrations associated with the workings of internal organs. As indicated by the FDA...
Nanox
By  Laura Lovett 12:25 pm April 2, 2021
Israeli imaging startup Nanox has landed FDA clearance for its single-source digital X-ray Nanox.ARC, the company announced today. Nanox came on the imaging scene pitching to lower costs and sell its system via a price-per-scan model. The company’s system combines an in-hospital scanning device with a companion cloud software tool. The X-ray device, which just landed the single-source clearance,...
COVID 19, vaccine
By  Ahmed El Sherif 12:18 pm April 1, 2021
The United Arab Emirates (UAE) has become the first country in the Arab world to begin manufacturing a COVID-19 vaccine with a full production schedule underway. Hayat-Vax, a joint collaboration between Sinopharm CNBG and Abu Dhabi’s G42, was announced earlier this week during the launch of a new purpose-built research and development hub for life sciences, biotechnology and vaccine production in...
Health technology assessment, regulation
By  Tammy Lovell 06:03 am March 31, 2021
The European med tech industry has called for patient access to innovative technologies to be preserved under a new legislative proposal. Last week, the European Council agreed to start negotiations with the European Parliament concerning joint work on the EU Health Technology Assessment (HTA) Regulation. The Council called for the establishment of a coordination group comprising national health...
By  Dave Muoio 02:52 pm March 30, 2021
Oxford University spinoff Oxehealth has received an FDA De Novo clearance for software that can estimate pulse rate, heart rate, respiratory rate and breathing rate from a video camera signal. Founded in 2012, the company has often likened its technology to that of a pulse oximeter, which detects minute visual changes in skin color to measure blood oxygen levels. In this case, the Oxehealth Vital...