Regulation

By Dave Muoio 04:00 pm September 22, 2020
The FDA announced today the launch of the Digital Health Center of Excellence, a central resource intended to help the agency as well as external stakeholders promote digital health technologies. Housed within the Center for Devices and Radiological Health (CDRH), the Digital Health Center of Excellence (DHCE) will focus on a range of technologies "mobile health devices, Software as a Medical...
By Laura Lovett 03:16 pm September 17, 2020
For digital therapeutics companies, the FDA has often been viewed as the gatekeeper to getting products to the patients. However, today the conversation around efficacy and research is branching beyond just what ticks the FDA boxes, into what kinds of studies are needed to meet the expectations of stakeholders and end users. This morning at DTx East, a group of panelist discussed the current...
By Laura Lovett 02:49 pm September 15, 2020
Capsule Technologies, a medical device-maker (not to be confused with digital pharmacy Capsule), has just landed FDA 510(k) clearance for its new connected capnography-monitoring technology.  Called Vitals Plus monitoring solution, it was created to incorporate Masimo's NomoLine ISA CO2, and designed to keep track of a patient's end-tidal carbon dioxide, respiratory rate, and fractional inspired...
By Mallory Hackett 11:44 am September 14, 2020
Fitbit’s new electrocardiogram app has officially received regulatory clearance in the U.S. and European Union for its latest smartwatch, the Fitbit Sense, to monitor heart rhythm and detect atrial fibrillation. Now that the app has 510(k) clearance from the U.S. Food and Drug Administration and CE marking, Fitbit Sense users can access the ECG app beginning in October. The company conducted a...
By Tammy Lovell 01:27 pm September 7, 2020
The UK government has released a proposed regime on the regulation of medical devices in Great Britain, Northern Ireland and the European Union post Brexit. Under the guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognise CE marks and certificates issued by European Economic Area-based Notified Bodies until 30 June 2023. From 1 July, companies will...
By Laura Lovett 11:59 am September 1, 2020
Medtronic’s MiniMed 770G System has landed FDA clearance for its hybrid closed-loop system, marking the first time an automated insulin delivery system was greenlighted for young children with Type 1 diabetes.  This clearance means that the tool can be marketed to children as young as 2. It can also be used for adults. The system includes an algorithm which is able to measure a patient’s glucose...
By Laura Lovett 03:03 pm August 31, 2020
Connected care company Masimo has landed and expanded FDA clearance for its O3 Regional Oximeter, for both somatic applications and monitoring changes in the cerebral hemoglobin.  It specifically monitors somatic tissue oxygenation saturation, and can detect changes in a patient’s hemoglobin, oxyhemoglobin and deoxyhemoglobin.  According to the company, its tool differs from peripheral pulse...
By Dean Koh 05:02 am August 27, 2020
CureApp Inc., a Tokyo, Japan-headquartered software-as-a-medical-device (SaMD) startup, has received regulatory authorization for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker” (CureApp SC) from the Ministry of Health, Labour and Welfare (MHLW) on 21 August, 2020. The startup is currently proceeding with plans to...

A product image of the existing AncestryHealth offering.

By Dave Muoio 03:15 pm August 24, 2020
Consumer genomics company Ancestry recently received two FDA 510(k)s – one for an in vitro molecular test that detects genomic variants tied to potential disease risk, and another for a saliva-based DNA specimen-collection kit. Both of these submissions were received by the FDA in October of last year, which officially cleared them on August 13, according to the agency's 510(k) database. Each was...

Credit: Myomo

By Dean Koh 01:20 am August 24, 2020
Cambridge, Massachusetts headquartered wearable medical robotics company Myomo last week announced that a Myomo-trained Orthotic & Prosthetic (“O&P”) practice in Australia has received its first insurance authorization to fit a patient with a custom MyoPro device. The practice, X-Tremity Prosthetics and Orthotics, is located in New South Wales and is operated by Jens Baufeldt. It is...