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Start-Up Spotlight: Cognoa Seeks Breakthrough In Early Diagnosis Of Autism And ADD

US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. The average age of ASD diagnosis is about four years old, but extensive clinical research has shown that earlier diagnosis of ASD can improve outcomes over the child’s lifetime. Cognoa’s system is intended to allow primary care physicians to diagnosis ASD in the children as young as 18 months.

Starts & Stops Diagnostics Companies

Latest From Innovation

Podcast: Legal Expert Advises On Patentable Subject Matter As Courts Send Conflicting Message

Three major cases have provided different interpretations of what is considered patentable subject matter, and to top it off a new guideline from the US Patent and Trademark Office has added to the confusion, according to a legal expert. Harness Dickey’s Chris Cauble walks us through what patent-seekers need to know and how to prepare their patent filings in this interview (podcast and transcript).

Intellectual Property Innovation

Device Week, Feb. 13, 2019 –  Femtech Draws Investment; Smith & Nephew/Nuvasive Merger Rumors Emerge

In this edition of Device Week, Medtech Insight’s Reed Miller talks to managing editor Marion Webb about the growing interest among investors in "femtech," technology that specifically addresses women's health issues that have been frequently overlooked in the past. And London-based reporter Catherine Longworth addresses the recent media reports that Smith & Nephew may make a bid for spine-device company Nuvasive.

Device Week Business Strategies

Market Intel: Let's Talk About It — The Rising Tide Of 'Femtech' Companies

Femtech, which describes digital technologies that aim to improve women's health, is expected to reach $50bn in market size by 2025, according to Frost & Sullivan. Reproductive health and menstrual health trackers are two of the fastest-growing sectors in femtech. We've highlighted some of the biggest players in both segments, their innovative business models, plans and also looked at barriers such as privacy issues, accuracy of mobile applications and funding challenges.

Market Intelligence Commercial

Start-Up Spotlight: Vetex Brings Clot-Removal Technology To Venous System

The venous thrombectomy market has historically been under-served, especially compared to the arterial thrombectomy space, because the venous clots are more challenging to remove mechanically. But Galway, Ireland-based Vetex believes their technology, which combines a grasping and rotating action, will become the first-choice treatment for removal of large, difficult-to-remove venous clots in patients with venous thrombo-embolism, without the need for thrombolytic drugs.

Start-up Spotlight Clinical Trials

Device Week, Jan. 31, 2019 – Livongo's Acquisition Of myStrength; FDA Evaluates Peripheral Paclitaxel Devices Study

In this edition of Device Week, Medtech Insight's Catherine Longworth chats with Marion Webb about Livongo's acquisition of behavioral health company myStrength and with Reed Miller about the controversy surrounding the meta-analysis finding of a higher mortality risk with paclitaxel-eluting peripheral devices. 

Device Week Clinical Trials

Livongo Buys Behavioral Health Firm In Multimillion Dollar Deal, Plans To Hire 300-500 People

Livongo, which developed a digital platform for managing chronic conditions, announced Jan. 30 it acquired myStrength, a Denver-based digital behavioral health company. The company didn’t disclose financial details, but Livongo's executive chairman Glen Tullman told Medtech Insight the acquisition cost was in the "tens of millions of dollars."

Commercial Digital Health

SCAI, Manufacturers Defend Peripheral Paclitaxel Devices Against Doubts

The Society for Cardiovascular Angiography and Interventions’ Vascular Disease Council says the recent meta-analysis finding a higher long-term mortality risk with paclitaxel-eluting peripheral devices can only be viewed as hypothesis-generating. The long-term risks of these devices should be investigated with patient-level data, SCAI argues. Several clinical data presentations at the recent LINC meeting in Leipzig showed comparable mortality rates with paclitaxel-eluting devices as comparable non-drug-eluting devices.

Clinical Trials FDA

QUOTED. Jan. 30, 2019. Joerg Kruetten.

The European medtech sector will face multiple challenges in 2019, according to new survey data that uncovers declining optimism reported by EU medtech executives. See what Joerg Kruetten, from Simon-Kucher & Partners, has to say about it here.

Quoted Leadership

US FDA Approves Abbott’s Sensor-Enabled TactiCath AF Catheter

The TactiCath - Sensor Enabled contact-force ablation catheter is indicated for cardiac electrophysiological mapping and the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. It adds to Abbott EnSite Precision cardiac mapping system.

Approvals Innovation
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