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
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
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
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
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
May 05, 2020 It took this action more than a week before it announced in mid-April that it would use the little-known aspect of the law to force 3M to fill its contract to the U.S. first. Firms face fines or jail time if they do not comply. The Cold War-era law gives federal officials … Read more
April 30, 2020 In the U.S., emergency plans developed by states for a shortage of ventilators include using positive airway pressure machines — like those used to treat sleep apnea — to help hospitalized people with less severe breathing issues. While that measure could stretch the supply of ventilators and save lives, it has a … Read more
April 28, 2020 This includes modified anesthesia gas hardware and positive-pressure breathing devices — as well as home continuous positive airway pressure, or CPAP, machines used to treat sleep apnea, plus portable oxygen generators for chronic obstructive pulmonary disease and nasal cannula hoses. However, the American Society of Anesthesiologists put out guidance in February 2020 … Read more
April 23, 2020 While overall testing capacity of any kind remains far short of meeting demand, antibody blood tests would provide additional data on the spread of the novel coronavirus, and results showing immunity could be used to give people an all-clear to leave quarantine and return to work. Their accuracy would, of course, have … Read more
April 21, 2020 The serological test — which uses a few drops of blood drawn from a vein and dropped into a device containing a small strip, similar to a combination of a blood glucose test and a home pregnancy exam — detects two different types of antibodies produced by the body to fight off the … Read more