Belmont Instruments acquires Israeli temperature management firm MTRE Advanced Technologies

Belmont Instrument (Billerica, Mass.) recently acquired MTRE Advanced Technologies. The financial details of the deal were not disclosed. The acquisition allows Belmont to extend its portfolio to include non-invasive body temperature management solutions. MTRE’s normothermia management products include the Allon system and ThermoWrap disposable garment, as well as the temperature management portfolio including the CritiCool system

Medtech venture investing trends: Here’s what you need to know

Ask any early-stage medtech or digital health entrepreneur, and they’ll tell you how tough it is. There’s tremendous competition for venture investing, coupled with a pullback by previously traditional investors in this space. Bill Evans While venture investment in medtech and digital health has recovered since the financial crisis of a decade ago — setting

Medtech stories we missed this week: June 22, 2018

From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India

White House proposes 30% cut to FDA headcount, reorganization

The Trump administration this week submitted a proposal that would cut the budget and staff at the FDA, as well as reorganizing the agency to remove food regulation from its purview, according to a new Endpoints News report. The proposal would cut $1.3 billion in resources from the agency and 5,000 members of its staff […]

Johnson & Johnson hits the Big Apple with latest JLabs site

Johnson & Johnson (NYSE:JNJ) opened its latest life science incubator in New York City, the healthcare giant said today. The 30,000-square-foot JLabs @ NYC is a collaboration between Johnson & Johnson Innovation, New York State and the New York Genome Center. Sited at the genome center in SoHo, the incubator is home to 26 startups and

Resonetics acquires Swiss manufacturer Medelec

Resonetics (Nashua, N.H.) announced today that it has acquired Medelec (Puidoux, Switzerland). The financial details of the deal were not disclosed. “We are excited about the Medelec team joining Resonetics. Marc and Sandra But have established a very strong reputation in the medtech industry for precision and quality and have made significant investments in technology

Medical devices: When should you make them smarter?

The drive toward value in healthcare has increased demand for smarter medical devices able to provide information for real-time feedback, as well as after-the-fact analysis. So when does it make sense to actually make a medical device smarter? And how do you go about it? Tom KraMer, CEO of Kablooe Design outside Minneapolis, has a

Bluebee receives ISO 13485 certification

Bluebee recently announced that it has received ISO 13485 medical device quality standard certification for its design and development of software solutions and data processing algorithms intended for use in diagnostics and clinical reporting. The certification body BSI certified that Bluebee’s design, development, installation, testing and servicing of custom-made software solutions and data processing algorithms

Stocks slide further as Trump doubles down on China tariffs

The Trump administration yesterday added $200 billion worth of tariffs to the $50 billion in trade levies already slated to go into place next month and threatened to add $200 billion more, sending share prices down. The news put the Dow Jone Industrial Average on track for its longest losing streak in 15 months and

Bronchoscopes still dirty after cleaning, study says

A new study has found that currently acceptable methods of reprocessing reusable bronchoscopes left most devices contaminated and damaged. “The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” said the study, funded by 3M and

Bay Labs wins FDA clearance for AI-based echocardiogram analysis

Bay Labs has received 510(k) clearance from U.S. FDA for use of its EchoMD AutoEF software product to provide fully automated clip selection and calculation of left ventricular ejection fraction (EF), the San Francisco–based company said today. The EF is the percentage of blood leaving a heart each time it contracts. Bay Labs in its news release

Singapore HSA implements major medical device regulatory changes

By Stewart Eisenhart, Emergo Group Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only

Study finds nearly half of people with diabetes skip care due to costs

A newly-published report from UpWell Health found that nearly half of Americans with diabetes have skipped medical care at times because they couldn’t afford it. The 5,000-person survey showed that diabetes doesn’t just take a financial toll on people’s lives – it can impact their relationships, too; 37% of respondents reported that diabetes has harmed

Paragonix Technologies aims to boost survival of donated lungs

Many lungs being transported for transplant arrive in such bad shape that they cannot be used. Paragonix Technologies aims to change that with SherpaLung, a specialized cooler that keeps lungs properly inflated and at the right temperature to survive an airplane trip. Paragonix Technologies just landed support from the Lung Transplant Foundation to continue developing and commercializing

DreaMed Diabetes wins FDA authorization to market insulin therapy management platform

DreaMed Diabetes said today that U.S. FDA has granted a de novo request for DreaMed Advisor Pro, its AI-based diabetes treatment decision support software. The news comes about four months after the Petah Tikva, Israel–based company won CE Mark clearance for the decision-support platform, which is meant to help healthcare professionals manage insulin therapy for people with Type