NE Ohio biomedical industry investments on the rise

Investment in the northeast Ohio biomedical sector totaled nearly $294 million in 2018 with 71 regional companies receiving funding, according to regional healthcare trade group BioEnterprise. Those figures make this region the third largest for total healthcare investment in the Midwest, following Minneapolis ($664 million) and Chicago ($551 million).

These were among the findings of BioEnterprise’s 2018 Midwest Healthcare Growth Capital Report, which tracks capital investments made in biomedical companies across 11 Midwestern states in three sectors — medical device; biotechnology and pharmaceuticals; and health IT/software and services. The $294 million invested in northeast Ohio is the second largest in the history of the report, and the 71 companies receiving funding is the highest ever. Northeast Ohio is also the second largest region for the number of companies funded across 11 Midwest states. Minneapolis leads with 83 companies receiving funding.

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Taking a more rigorous approach to investigating fatal medical errors in the U.S.

Emergo GroupBy Stewart Eisenhart, Emergo Group

On Friday, March 1, 2019, a Tesla automobile was involved in a fatal crash in Palm Beach, Florida. Considering the possibility that the vehicle crash occurred while the vehicle was in autopilot mode, the National Highway Traffic Safety Administration (NHTSA) and the National Transportation Safety Board (NTSB) initiated an investigation of the accident.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Carbon debuts dental technology platform

Carbon’s L1 3D printer (Image from Carbon)

3D printing company Carbon is unveiling an integrated technology platform for the dental market this week at the International Dental Show in Cologne, Germany.

The platform combines software, hardware and materials in an end-to-end solution designed to meet the needs of dental and orthodontic labs and enable them to scale quickly and economically, according to the Redwood City, Calif. company. Carbon is also debuting its new M2d printer for mid-sized dental and orthodontic labs with lower volume needs, as well as its L1 Production Solution for high-volume production of clear aligner models. And it is announcing new dental resins and a materials initiative for creating recyclable dental models.

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Nyxoah sleep apnea neuro-stim therapy gains CE Mark

NyxoahNyxoah said it has won the CE Mark for its novel hypoglossal nerve stimulation therapy for treating obstructive sleep apnea (OSA).

The Genio system is a battery-free, leadless and minimally invasive neurostimulator designed to deliver bilateral hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea patients who have failed conventional continuous positive airway pressure (CPAP) therapy.

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Ex-NuVasive CEO Lucier to head new M&A firm

Ex-NuVasive CEO Gregory Lucier will lead new M&A-focused company Corza Health.

Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets.

Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and Sotera Health along with life sciences, technology, and financial and business services companies.

Get the full story on our sister site, Medical Design & Outsourcing.

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Study shows catheter ablation for Afib significantly boosts quality of life

Patients who had catheter ablation for atrial fibrillation (Afib) had fewer symptoms, a significant long-term improvement in quality of life and fewer recurrences and hospitalizations than those who received drug therapy alone, according to a government-funded study.

The same study showed that catheter ablation appeared no more effective than drugs in preventing strokes, deaths, and other complications.

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GI Dynamics touts results of U.K. study

GI DynamicsGI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients.

The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract, according to the Lexington, Mass.-based company.

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FDA ramps up scrutiny of materials in medical devices

(Image by Michael Longmire on Unsplash)

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

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Oberd launches AI-assisted tech for gathering outcome data

Patient-reported outcomes vendor Oberd said it has launched software designed to reduce a patient’s time in completing outcomes surveys for orthopedic procedures.

Patient-reported outcomes can help quantify the value of a healthcare provider’s services. Columbia, Mo.-based Oberd’s computer-adaptive test (CAT) software has been developed and validated for all of the outcomes surveys approved by the American Academy of Orthopaedic Surgeons (AAOS). The technology, which uses artificial intelligence (AI), has been used in both test and live settings by the Geisinger Health System and will be featured in an article in the Journal of Shoulder and Elbow Surgery, according to the company.

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10+ orthopedic products from AAOS 2019 you need to know

Attendees line up to register for the American Academy of Orthopaedic Surgeons annual meeting in Las Vegas this week. More than 30,000 people were expected. (Image from AAOS)

The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink.

While the SVB Leerink analysts termed Stryker’s  (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing ones.

Johnson & Johnson (NYSE:JNJ), for example, said it plans to debut its Orthotaxy total knee system in 2020, with spine, hip and eventually shoulder indications likely to follow. J&J bought the French robot-assisted surgery startup in 2018, and didn’t have any photos of the prototype to share. But the analysts said it attaches to the patient table and includes a saw/bone cutting capability, like Mako. Unlike Mako, it will not have haptic capability. Rather, it gets the surgeon locked into a cutting plane and preserves the surgeon’s control of the saw (side to side and front to back) on that plane.

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