Regulation

By  Dave Muoio 03:53 pm March 26, 2020
Pear Therapeutics announced this morning that Somryst, its prescription digital therapeutic for adults with chronic insomnia, has received marketing authorization from the FDA. The treatment provides cognitive behavioral therapy for insomnia (CBTi) alongside personalized, algorithm-generated sleep restriction recommendations. The digital therapeutic was reviewed through the agency's 510(k)...
By  Dave Muoio 03:56 pm March 25, 2020
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA. The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...
By  Dave Muoio 04:32 pm March 23, 2020
Last week saw a number of diagnostic testing startups, telehealth providers and others announce new services that would deliver at-home COVID-19 testing-kits to consumers. But the majority of these of offerings have since been rescinded or hang in doubt thanks to new warnings and regulatory clarifications issued this weekend by the FDA. On Friday evening, the agency released an alert to consumers...
By  Dave Muoio 04:50 pm March 20, 2020
The FDA announced today a new policy that permits expanded use of connected, non-invasive remote vital sign monitors until the end of the COVID-19 public health emergency. The agency is relaxing its prior guidance so that healthcare teams can monitor their patients outside of the hospital with certain devices that were previously cleared by the FDA, thereby freeing up space for the high volume...
By  Laura Lovett 04:07 pm March 11, 2020
Women’s health company Proov got the FDA green light for its at-home ovulation testing kit.  Users can send away for the kit and get test strips, which can determine the presence of progesterone metabolite PdG in urine, which is linked to a woman's ovulation cycle.  The test was developed to help women find out if they are ovulating on a regular basis.  In the spring, the company will roll out...
By  Leontina Postelnicu 07:48 am March 9, 2020
The UK government has announced this morning that it is setting up a unit to counter the online spread of inaccurate and false information relating to the new coronavirus. The team will be tasked with identifying and, where necessary, responding to claims that aim to deceive or mislead people. The department for digital, culture, media and sport (DCMS) said it was working with communications...
By  Laura Lovett 02:09 pm March 4, 2020
Google made waves in the fall when the WSJ reported that the tech company had been working with Ascension since 2018 on a collaboration involving patient data, called Project Nightingale. While the partnership appears to be HIPAA compliant, the news drew concerns among patients, providers and legislators. Earlier this week, a group of three senators, including Elizabeth Warren (D-MA), Richard...
By  Laura Lovett 01:41 pm March 2, 2020
Last week the FDA greenlighted the ultrasound app VistaScan from Emagine Solutions Technology.  The new software app can be used on a doctor's cellphone or tablet. It can also connect with companion ultrasound probes, which are already FDA cleared.  The company previously partnered with the Red Cross to assist women with prenatal scans, according to a video on the company’s website. WHY IT...
By  Tammy Lovell 05:15 am February 12, 2020
The countdown is on for medical device manufacturers to prepare for the EU Regulation on Medical Devices (MDR), which will fully apply in member states from May this year. But in a recently published paper, trade association MedTech Europe raised concerns that the new regulatory system is not ready to support the transition of technology from the old regime. The new EU MDR came into force on May...
By  Dave Muoio 04:38 pm February 7, 2020
The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA announced today. Developed by Caption Health, the Caption Guidance tool guides medical professionals through a heart disease diagnostic test that normally requires an ultrasound expert. “Echocardiograms are one of the most widely-used diagnostic tools in the diagnosis and...