T2 Biosystems (NSDQ:TTOO) this week said it received CE mark approval for its T2Resistance Panel. The panel is designed to detect 13 drug resistance genes in a blood sample. This can include genes that indicate a resistance to antimicrobial drugs that can affect the treatment of bacterial infections. “Fighting antimicrobial resistance not only requires the development […]
GenapSys secures $90 million in bid to upend sequencing
Following the raising of a $90 million Series C, privately held GenapSys will begin rolling out a line of low cost electronic-based genetic sequencing machines that it says could upend the research and clinical testing industries. CEO Hesaam Esfandyarpour says the Redwood City, Calif.–based company’s Sequencer, a table-top device that carries a price tag that’s […]
Owlstone Medical partners with Thermo Fisher Scientific for breath biopsies
Owlstone Medical last week announced that it has forged a partnership with Thermo Fisher Scientific‘s (NYSE:TMO) to advance non-invasive breath sampling in disease detection. Through the agreement, both companies will integrate the Thermo Scientific Q Exactive GC Hybrid Quadrupole-Orbitrap MassSpectrometer into Owlstone Medical’s Breath Biopsy platform. The collaboration will hopefully qualify the mass analyzer for detecting biomarkers […]
Former Theranos CEO wrangles with FDA over missing emails
As she prepares to face a criminal trial over federal wire fraud charges, discredited Theranos founder Elizabeth Holmes is arguing with the FDA over missing emails, according to media reports. Lawyers for Holmes and former Theranos president Sunny Balwani used a hearing yesterday in federal court in Northern California to criticize the FDA for failing […]
AliveCor inks wearables deal with Huami
AliveCor said yesterday that it entered into a strategic partnership with Huami Corp. (NYSE:HMI) to combine each company’s technologies for developing medically functional wearable devices. The financial details of the agreement were not disclosed but the company said the agreement includes the licensing of AliveCor technology and a deal to bring new devices and services to […]
Potrero Medical adds $5.5m
Predictive health company Potrero Medical today filed an SEC Form D/A disclosing the sale of nearly $5.5 million in equity. The amendment the equity offering which made its first sale on June 28. At that time, the offering was for a total of $15 million and, in July, the company announced that it sold $11.7 million […]
AliveCor raises $6m for mobile ECG devices
AliveCor said it raised nearly $6 million in equity financing for its mobile electrocardiogram devices. The Mountain View, Calif.-based company said nine investors put up a collective $5.8 million toward its $9.2 million goal. The first sale was Oct. 15, according to the filing. AliveCor makes the KardiaBand, a wrist-worn device that is designed to […]
AI-powered radiology model diagnoses pneumonia in 10 seconds
Intermountain Healthcare and Stanford University researchers developed an AI system that can detect pneumonia in chest X-rays in about 10 seconds. CheXpert, developed by researchers at Stanford University, is an automated chest X-ray interpretation model that uses artificial intelligence to analyze X-ray images take in emergency departments. A study found that the AI system could […]
MedTech Innovator announces five finalists in competition
MedTech Innovator last week announced the five finalists for its $500,000 competition. The organization will award more than $500,000 in prizes to the finalists with first place taking $350,000 and the four remaining finalists taking $25,000. Five finalists will have seven minutes to pitch their technologies to a panel of four judges. The audience will […]
Eitan Group inks Canadian distribution deal for Sapphire infusion pumps
Eitan Group today announced it signed a distribution agreement with Canadian Hospital Specialities to distribute its Sapphire infusion pumps in Canada. Through the agreement, Canadian Hospital Specialties will supply and support Israel-based Eitan Group’s Sapphire infusion pumps to hospitals and alternate site customers in Canada. Get the full story on our sister site, Drug Delivery Business.
DreaMed wins clearance, CE Mark for AI-powered insulin dosing software
DreaMed Diabetes today said it received FDA 510(k) clearance and CE Mark approval for its DreaMed Advisor Pro software. DreaMed Advisor Pro is an AI-based insulin dosing decision supply software designed for people with Type 1 diabetes using insulin pump therapy with continuous glucose sensors or blood glucose meters. The software previously received CE Mark approval […]
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