Bio-Rad Laboratories (NYSE:BIO) said late Friday afternoon that it is making good progress recovering from a ransomware attack that was detected on the company’s network on December 5. The company did not reveal the hacker’s demands, if any. Once the malicious software was detected, Bio-Rad immediately took certain systems offline, the company said in a […]
FDA clears first single-use duodenoscope from Boston Sci
The FDA today said it cleared the first fully disposable duodenoscope, made by Boston Scientific. The EXALT Model D Single-Use Duodenoscope is designed for use in endoscopic retrograde cholangiopancreatography procedures. It is the first single-use duodenoscope on the market and was granted Breakthrough Device Designation. “The availability of a fully disposable duodenoscope represents another major […]
FDA approves Tandem Diabetes’ advanced hybrid closed-loop controller
The FDA today cleared the Tandem Diabetes Care (NSDQ:TNDM) t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology to control Type 1 diabetes. The agency also granted De Novo clearance to the Control-IQ device, which is compatible with a variety of continuous glucose monitors and insulin pumps. The t:slim system, which also includes the recently approved Dexcom […]
Awak Technologies raises $40m
Awak Technologies announced today that it raised $40 million in an oversubscribed financing round as it readies its Awak PD (peritoneal dialysis) device. Singapore-based Awak said the latest funding is earmarked for late-stage clinical studies and commercialization acceleration for the portable, wearable PD device that does not require medical supervision when administered. The device is […]
Sterigenics’ legal troubles mount in Illinois
Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs. That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five firms involved in the […]
Caresyntax to acquire Syus; raises $45.6m
Caresyntax announced today that it acquired operating room operations and cost analytics company Syus for an undisclosed amount after it raised nearly $46 million. The company closed a total of $45.6 million in financing from Whiz Partners, a Takeda-backed drug-discovery gateway fund, along with Plug and Play, Barco Healthcare, Mitsubishi, Relyens, IPF Partners and Caresyntax […]
Nihon Kohden launches new patient monitor
Nihon Kohden (TYO:6849) announced the U.S. launch of its Life Scope SVM-7200 series vital signs monitor for outpatient facilities and beds that aren’t continuously monitored. The Life Scope SVM-7200 is designed to provide customizable early warning scoring to help clinicians identify patients who are deteriorating or at risk of deterioration. It combines vital signs data with […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer […]
Flexicare recalls fiber optic laryngoscope blades and handles
Flexicare Medical today issued a recall for its BritePro Solo and BriteBlade Pro single-use fiber optic laryngoscope blades and handles due to a risk of choking. According to a medical device alert pertaining to England, Scotland, Wales and Northern Ireland, the BritePro Solo and BriteBlade Pro contain loose bearings and a retaining ring that may […]
3M to sell drug-delivery biz to Altaris Capital Partners for $650m
3M (NYSE:MMM) announced today that it entered into an agreement to sell most of its drug-delivery business to an affiliate of Altaris Capital Partners for approximately $650 million. St. Paul, Minn.-based 3M will retain its transdermal drug delivery components business, according to a news release. The business being divested has annual global sales reaching approximately […]
GI Windows raises $15m Series A
GI Windows announced that it raised nearly $15 million in Series A financing for its next-generation technology for clinical procedures and tissue fusion. The West Bridgewater, Mass.-based, clinical-stage company said the $14.6 million financing round was led by Asia-focused healthcare investment firm GT Healthcare Capital Partners, as well as Sonder Capital. Proceeds from the funding […]
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