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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Nov. 22, 2019

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Study supports long-term performance of Senseonics’ Eversense CGM

Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults. Read More

Witnesses urge quick action on APJ dismissal question raised in Arthrex

The case of Arthrex v. Smith & Nephew, Inc., has raised a host of questions about the appointment of judges to the Patent Trial and Appeal Board (PTAB), and witnesses at a congressional hearing said a Supreme Court review might be two years in coming. Any such resolution might not clear out the thicket of underlying legal questions, however, and thus the witnesses urged Congress to take action quickly even as the Federal Circuit considers an en banc hearing of the matter. Read More
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Patients to payers: Can you hear me now?

Patient engagement has become more than a buzzword for the FDA and drug and device developers. But for payers, not so much. When valuing new drugs and devices, payers often undervalue or ignore what they may consider convenience updates, giving little to no consideration to the difference a seemingly minor improvement could make to patients debilitated by fatigue, pain, the burden of treatment and the burden of a disease itself. Read More

Eyegate sees top-line corneal wound win as unlocking path to U.S. de novo filing

Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery. The pivotal top-line data will allow the Waltham, Mass.-based company to submit a de novo application to the FDA for commercialization in the first half of 2020, said CEO Stephen From. If approved, the OBG eye drop would be the first product indicated to repair corneal epithelial defects, as well as the first prescription hyaluronic acid (HA) eye drop in the U.S., creating new competition for widely used bandage contact lenses (BCL). Read More
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Opsens expands core technology into growing structural cardiology space

TORONTO – If you’ve successfully expanded your medical technologies business once, why not do it a second time? The answer was quick in coming Nov. 5, when Quebec City-based Opsens Inc. announced its next goal: To accelerate development of products beyond its current line of technologies for measuring coronary pressure into the structural cardiology space. Read More
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Apple Heart Study delivers results as 3 new app-based trials begin

Stanford University School of Medicine and Apple Inc.have published results from the largest digital-only study. The trial has been conducted in more than 400,000 people in the U.S. over more than eight months. It was set up to screen participants via their Apple Watch for heart irregularities and then to further monitor any of those with identified issues with a wearable ECG patch. Read More

Appointments and advancements for Nov. 22, 2019

New hires and promotions in the med-tech industry. Read More

Financings for Nov. 22, 2019

Med-tech firms raising money in public or private financings. Read More

In the clinic for Nov. 22, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Nov. 22, 2019

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Regulatory actions for Nov. 22, 2019

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

Bioworld MedTech’s Neurology extra

Keeping you up to date on recent developments in neurology. Read More

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