Editors’ Choice: 2020 in Medtech

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2020 will be remembered as the year marked by COVID-19. The profound impact of the pandemic can be seen in every aspect of our existence, from people’s everyday lives to businesses, economy, global politics and international mobility.

The medical device industry wasn’t spared either – slowdown in investments, halt in clinical trials, and shifting to the work-from-home reality of doing business marked the past 12 months and could well be here to stay.

Despite the tough challenges and its key role at the forefront of the battle against the outbreak, medtech kept growing. So let’s take a look at the most popular events that marked 2020 across innovation, clinical trials, regulatory, M&A and funding according to the Guided Solutions LinkedIn community in our traditional end-of-year recap:

Innovation

New robot does superior job sampling blood

Robots taking blood samples, benefiting patients and healthcare workers alike…does this sound like the future? Not anymore! A Rutgers-led team created a blood-sampling robot that performs just as well or better than humans, according to the first human patient clinical trial.

The automated blood drawing and testing device has overall success rate of 87% across the total 31 trial participants, and 97% for the 25 whose veins were easy to access. It provides quick results and would allow healthcare professionals to spend more time treating patients in hospitals and other settings.

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True Digital Surgery and Aesculap AG launch the Aesculap Aeos Robotic Digital

Amidst the challenges of the COVID-19 pandemic, TDS and AESCULAP launched the innovative Aesculap Aeos Robotic Digital Microscope to improve safety and efficiency during surgeries, as the heads-up display can be viewed simultaneously by all healthcare workers in the operating room while wearing PPE.

The innovative Image Modes feature delivers augmentation without the need for an overlay, including 3D details with outstanding depth-of-field, fluorescence backlighting and a 10x optical zoom that delivers full resolution regardless of magnification level. As an exclusively digital microscope platform, it can be customized with simple software updates.

“We are proud to bring the fully-digital Aesculap Aeos Robotic Digital Microscope to market, with breakthrough technology that we like to say can ‘see beyond the tissue’ and provide a solution to the limitations of conventional surgical microscopes,” said Aidan Foley, Chairman and CEO of True Digital Surgery.

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Olympus launches new AI platform for endoscopy system

By designing and delivering advanced medical technologies and solutions for medical and surgical procedures, Olympus aims to improve the health and quality of life of patients. Its latest endoscopy system, EVIS X1 improves image detection, characterisation, staging, and treatment. With the newly introduced endoscopy CAD (computer-aided detection and diagnosis) platform ENDO-AID, Olympus has enhanced the capabilities of EVIS X1 through AI technology. The ENDO-AID platform includes the endoscopy application ENDO-AID CADe for the colon and offers real-time display of automatically detected suspicious lesions.

Frank Drewalowski, Head of Olympus Endoscopic Solutions division said: “We are committed to innovation and driving our research and development with passion. Considering ENDO-AID as a first step, we are planning additional AI-powered applications for image detection and characterisation that will elevate endoscopic imaging to uncharted levels.”

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Regulatory Approvals

US FDA approves Compumedics’ MEG neuroimaging technology enabling insurers to be billed

The Orion LifeSpan Magnetoencephalography single Dewar system is a neuroimaging technique that maps brain activity by recording magnetic fields generated by the brain’s natural electrical currents. The technology allows for a dual-helmet system, with one side optimised for adult MEG recordings and the other for children. Sites using Orion LifeSpan will be able bill insurers for MEG examinations.

“Much like MRI technology in the late 1980s which transitioned from research to clinical application, we expect MEG to follow a similar trajectory,” Compumedics Chairman and CEO Dr David Burton said.

The FDA greenlight for the MEG hardware follows the already approved Orion LifeSpan components including amplifiers, the simultaneous EEG subsystem, and the integrated co-registration, neuroimage processing and source estimation software – CURRY. This paves the way for the technology to be used routinely in clinical settings – primarily for epilepsy and pre-surgical brain function mapping.

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CryoLife secures CE Mark for On-X AAP for aortic root diseases

Headquartered in Georgia, CryoLife manufactures and distributes medical devices, as well as implantable tissues for cardiac and vascular surgical procedures that focus on aortic repair. The On X AAP device is a part of CryoLife’s On-X Heart Valve portfolio that consists of On-X Aortic Valve and ON-X Mitral Valve among other prosthetic heart valves. The approval enabled resumed distribution of the device in the EU.

On-X AAP is intended to treat damaged (or rectify malfunctioning of) native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. Aortic root diseases co-exist in almost as much as 10% of all aortic valve replacements.

CryoLife Chairman, President, and CEO Pat Mackin said: “The absence of the On-X AAP from the market since late 2016 has hindered our ability to compete for certain mechanical valve tenders in the EU. With the receipt of the CE Mark on the AAP, we once again have a complete portfolio of On-X products available in Europe, allowing us to be more competitive and potentially drive market share gains in the mechanical valve market.”

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ECG remote monitoring patch receives CE mark

LifeSignals, has received the CE mark for its ECG remote monitoring patch – a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, healthcare and home settings.

The LifeSignals Patch will be sold as a white-labeled device, marketed in Europe through a network of partnerships from OEMs and telehealth software providers to specialist hospital facilities. The patch is available immediately to interested partners. LifeSignals has also developed a cloud-based Holter Analysis platform, incorporating the use of LifeSignals patches, to facilitate the expansion of clinical remote ECG monitoring services.

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FDA approves Abbott’s Bluetooth connected pacemaker, defibrillator implants

The company’s Gallant line—including an implantable cardioverter defibrillator and a cardiac resynchronization therapy defibrillator—features Bluetooth technology, linking the devices with a personal smartphone app to help monitor patients with potentially life-threatening heart arrhythmias.

After pairing the device with Abbott’s myMerlinPulse software, patients and their clinicians can access data tracking the implants’ performance and event history. Care teams can also monitor patients remotely to identify episodes that may occur without any symptoms.

The MRI-compatible Gallant devices were launched in Europe back in February after Abbott received a CE mark. “The positive impact of remote monitoring has been proven repeatedly and leads to better patient outcomes and reduced burden on the healthcare system,” Abbott’s chief medical officer for its cardiac rhythm business, Avi Fischer, said at that time.

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Mergers & Acquisitions

Medtronic buys new spinal cord tech to boost pain therapies unit

Medtronic acquired Stimgenics, a Bloomington, Illinois-based startup that’s developed a novel spinal cord stimulation waveform Medtronic plans to deliver via its Intellis implantable neurostimulator to treat chronic pain.

The Stimgenics mechanism modulates both neurons and glial cells, the latter playing a greater role in chronic pain than previously understood. In a randomized controlled trial with 250 participants, researchers compared Intellis recipients whose devices had standard programming versus Stimgenics programming. Medtronic presented three-month outcomes from the study at the ​North American Neuromodulation Society (NANS) meeting in late January, and unvailed the latest version of the spinal cord stimulator​.

Spinal cord stimulation thwarts pain signals before they reach the brain through an implanted device that sends electrical pulses to the spinal cord area. Medtronic received FDA approval for its Intellis stimulator in 2017. The addition of Stimgenics’ tech, called differential target multiplexed (DTM) spinal cord stimulation, introduces a new mechanism of action for the device.

Medtronic’s addition to the unit comes amid broad deceleration in growth of the SCS market, where it competes with the likes of Abbott and Boston Scientific.

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ICON acquires MedPass International

ICON plc, a global provider of drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device industries, today announced that it has acquired MedPass International, the leading European medical device CRO, regulatory and reimbursement consultancy, that specialises in medical device development and market access.

This acquisition, concluded in late January, further enhances ICON’s Medical Device and Diagnostic Research Services, through the addition of new regulatory and clinical capabilities in Europe. The integration of MedPass International’s services brings noted expertise in complex class 3 medical devices, interventional cardiology and structural heart devices.

Founded in 1991 and headquartered in Paris, MedPass International is the leading European Medical Device CRO and consultancy. The company has served more than 1,000 medical device companies, from start-ups to multi-nationals, and has contributed to the development of hundreds of innovative devices including a number of breakthrough technologies.

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Funding

Medable tops off a strong year with US$91M funding round

Decentralized study company Medable has raised a large $91 million funding round as it continues to ramp up the deals in 2020. The series C is a major jump on its two previous rounds, more than doubling in one round the $45 million previously made in two, and was led by Sapphire Ventures with follow-on investment from existing investors GSR Ventures, PPD and Streamlined Ventures.

This also comes after the firm penned a series of deals with life science contractors including the likes of Datavant, PPD and Covance, as it looked to help CROs navigate choppy pandemic waters with its siteless trial model. There has been a real boon for these types of companies in 2020, as the COVID-19 crisis has ripped through the globe and halted thousands of trials, leaving regulators to recommend using the sort of virtual/siteless model Medable and others, like Science 37, offer.

This saw Medable grow its revenue by 500% this year as more companies signed up for its services, which allows trial teams to combine real-world health records, claims, diagnostic and other sources with their clinical trial data.

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