CDC coronavirus testing decision likely to haunt nation for months to come

May 28, 2020 Each kit contained material to test a mere 300 to 400 patients.  And labs, whether serving the population of New York City (NYC) or tiny towns in rural America, apparently received the same kits.  The kits were distributed roughly equally to locales in all 50 states.  That decision presaged weeks of chaos, … Read more

Illumina taps IDbyDNA for infectious disease sequencing co-marketing initiative

May 27, 2020 Both Illumina and IDbyDNA will co-market the latter’s Explify platform — a DNA search engine that can detect and profile over 50,000 microorganisms and 3,000 pathogens in the clinic, as well as antimicrobial resistance — for use on the sequencing giant’s hardware and library preparation systems.  Additionally, the two will collaborate on … Read more

TransEnterix nets FDA clearance for AI (Artificial Intelligence) vision-guided surgery

May 22, 2020 The company’s Intelligent Surgical Unit is designed as an add-on to its laparoscopic Senhance system, to help augment control of the surgeon’s camera during a minimally invasive procedure.  It was first submitted to the FDA for review in mid-January 2020.  “We are pleased to have received this important clearance earlier than expected,” … Read more

Tracking not just data, but individual symptoms, like vomiting: BioIntelliSense exits stealth with FDA-cleared wearable

May 19, 2020 Denver-based BioIntelliSense raised the curtain on its wearable BioSticker, which aims to do more than simply collect clinical-grade vital signs and raw activity data.  Using a combination of different sensors, it can track and identify distinct symptomatic episodes such as coughing, sneezing or vomiting. With a 30-day battery life, the BioSticker is … Read more

FDA warms of cybersecurity risks in Bluetooth Low Energy-equipped medical devices

May 14, 2020 Dubbed SweynTooth, the collection of 12 publicly available exploits could be used to wirelessly crash a device and stop it from functioning or access central user features.  The Agency said it is not aware of any adverse events related to these vulnerabilities.  “Medical devices are becoming increasingly connected, and connected devices have … Read more

FDA tightens oversight of antibody tests for COVID-19

May 12, 2020 Under its original policy, FDA said it would not object to the development and use of serological tests without FDA review or authorization so long as the tests were validated and the agency had been notified that the company planned to market the tests. More than 100 antibody tests were marketed under … Read more

The Colorado ski community that planned to test everyone for COVID-19

May 07, 2020 While the Centers for Disease Control and Prevention’s (CDC’s) tests for the virus that causes the respiratory illness have been in short supply since the outbreak began, this was a new type of test. It wasn’t to see who was sick right now.  It was an antibody test that would assess who … Read more