Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year. 

There are 10 listings in the first  group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.

While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.

Austin-based start-up Mosie received FDA clearance for a home insemination kit to help people get pregnant. The kit retails for $129.99.

Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year. 

IDA Ireland’s Rachel Shelly tells Medtech Insight about what is (and isn’t) driving investment in medtech. 

In this wide-ranging interview, lawyer Philip Desjardins talks about regulatory issues from AI to LDTs – as well as the passion for patient health that keeps him in the medtech arena.

The American Medical Association has written a set of principles for augmented intelligence (AI) development and deployment in health care. The organization hopes these principles can shape “a consistent governance structure for advancements in health care technology.”

The venture group has debuted Sofinova.AI, a software platform capable of viewing a potential investment in much more detail than a human.

While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.

Nevro is known for its spinal cord stimulation technology but wants to help a wide range of patients with chronic pain, so it is buying Vyrsa, which offers a complete system for sacroiliac joint fusion. In and interview with Medtech Insight, Nevro CEO Kevin Thornal explained how  Vyrsa supports Nevro's strategy in this growing market.

IDA Ireland’s Rachel Shelly tells Medtech Insight about what is (and isn’t) driving investment in medtech. 

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with Abbott’s head of Lingo Biowearables and top executives at Twin Health. Reed Miller provides an update on J&J MedTech’s launch of the Ottava soft-tissue robotic surgery system and Barnaby Pickering talks about his recent interview with Leo Grady, former CEO of Paige AI, to talk about his new start-up Jona.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML.

In this special podcast, Medtech Insight managing editor Elizabeth Orr talks to consultant Steve Silverman about the FDA’s current position on real-world evidence and real-world data, as well as how manufacturers can best put the evidence types to use.

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.

Consultant (and former FDAer) Steve Silverman is back with a reflection on his predictions for 2023, and well as what he expects to see in the coming year. 

The venture group has debuted Sofinova.AI, a software platform capable of viewing a potential investment in much more detail than a human.

There are 10 listings in the first  group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.

While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.

Austin-based start-up Mosie received FDA clearance for a home insemination kit to help people get pregnant. The kit retails for $129.99.

Nevro is known for its spinal cord stimulation technology but wants to help a wide range of patients with chronic pain, so it is buying Vyrsa, which offers a complete system for sacroiliac joint fusion. In and interview with Medtech Insight, Nevro CEO Kevin Thornal explained how  Vyrsa supports Nevro's strategy in this growing market.

IDA Ireland’s Rachel Shelly tells Medtech Insight about what is (and isn’t) driving investment in medtech. 

The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.

The US FDA is advising the public that certain plastic syringes from China could fail, leak, or break. If necessary, the agency may prevent Chinese syringes from entering the US.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

As the European Health Data Space Regulation heads towards a more intense discussion phase, EU member states still have concerns over patient data autonomy, data storage, and resources for developing national health data platforms.

The Belgian start-up is developing a scleral contact lens with an inbuilt LCD screen capable of filtering light – offering a non-surgical solution to a variety of ophthalmic conditions.