October’s top news stories

14 November 2017 (Last Updated November 14th, 2017 12:51)

US FDA granted 510(k) clearance to Royal Philips’ new eL18-4 PureWave linear array transducer, and Boston Scientific signed an agreement worth up to $300m to acquire Apama Medical and its radiofrequency (RF) balloon catheter system. Medicaldevice-network.com wraps-up the key headlines from October 2017.

October’s top news stories
This demonstrates Philips’ new MicroFlow Imaging. Credit: Koninklijke Philips NV.

FDA clears Philips’ new transducer for small parts imaging

The US Food and Drug Administration (FDA) granted 510(k) clearance to Royal Philips’ new eL18-4 PureWave linear array transducer, which offers a complete solution for the detection of abnormalities in small organs close to the skin through an ultrasound exam.

The Philips Ultimate Small Parts Solution includes MicroFlow Imaging, Elastography, and Precision Biopsy.

Available on Philips EPIQ 7 and 5 and Affiniti 70 ultrasound systems, the small parts assessment solution can be used for imaging diseases and disorders of small organs, including breasts, testicles and thyroid. It can also be used to detect musculoskeletal injuries such as sprains and tears.


Boston Scientific agrees to buy Apama Medical for $300m

Boston Scientific signed an agreement worth up to $300m to acquire Apama Medical and its radiofrequency (RF) balloon catheter system designed for the treatment of a common heart rhythm disorder called atrial fibrillation (AF).

Affecting more than 33 million people across the world, AF is commonly treated with anti-arrhythmic drugs and cardiac ablation, which is a process where energy is delivered to the areas of the heart muscle causing an abnormal rhythm.

The agreement includes an initial upfront cash payment of $175m from Boston and an additional $125m in contingent payments between 2018 and 2020 based on clinical and regulatory milestones.


US researchers develop surgical implant to accommodate child growth

Researchers from Harvard Medical School, Boston Children’s Hospital and Brigham and Women’s Hospital in the US developed a paediatric surgical implant that grows with the child.

By accommodating growth, the implant is intended to reduce the number of surgeries that have to be performed on a child with heart valve defects.

The researchers developed a proof-of-concept design to be used in a valve annuloplasty procedure for repairing a leak in the heart’s mitral and tricuspid valves.


US FDA finalises new guidelines for medical device development

The US Food and Drug Administration (FDA) announced new measures to promote medical device innovation and provide patients with fast access to beneficial technologies.

In addition to establishing modern tools for measurement of device safety and performance, the new steps include three new guidance documents to allow efficient and predictable development.

The organisation has completed the first qualification of a medical device development tool (MDDT), which is a 23-item questionnaire designed to measure health information such as health status and clinical symptoms reported by heart failure patients.


Flirtey and REMSA to launch AED drones for cardiac arrest victims in US

Regional Emergency Medical Services Authority (REMSA) collaborated with drone delivery service provider Flirtey to launch an automated external defibrillator (AED) drone delivery programme in the US.

The emergency drone service is intended to provide lifesaving defibrillators to sudden cardiac arrest victims.

Upon receiving a cardiac arrest call, REMSA’s 9-1-1 communications centre will dispatch an AED carrying the Flirtey drone and an ambulance to the scene.


CryoLife to buy Germany’s Jotec for $225m

US-based firm CryoLife signed a definitive agreement to purchase German vascular grafts maker Jotec for an upfront payment of $225m, subject to adjustments.

Jotec primarily focuses on the development of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts for aortic repair.

The acquisition is expected to allow CryoLife to offer a broad product portfolio for aortic surgery and enable the firm to compete in the growing endovascular surgical market.


Purdue researchers develop new diagnostic method for cancers

Researchers from Tymora Analytical Operations, a firm affiliated with Purdue University in the US, developed a new method to investigate the use of simple blood and urine tests for the detection of various early-stage cancers.

The researchers have previously demonstrated the ability of the blood test to identify and monitor breast cancer, while the urine test has been designed for bladder cancer.

It is expected that the new method could aid in early diagnosis of various other cancers and early signs of relapses.


Stryker purchases France’s Vexim for €162m

US-based medical technology firm Stryker purchased French company Vexim for €162m.

The deal sees Stryker gaining 50.7% share capital, 50.3% voting rights and 37.1% of outstanding BSAAR warrants.

Stryker paid a price that represents Vexim’s aggregated equity value on a fully diluted basis of around €183m, corresponding to the approximate €162m enterprise value.


Korea’s SNU develops new blood test technology for Alzheimer’s

Researchers at the Seoul National University (SNU) in South Korea reportedly developed a new technology for a series of blood tests designed to predict Alzheimer’s disease before the appearance of symptoms.

While the exact cause of the disease is not known, it is believed to occur due to the build-up of a beta-amyloid protein that is considered toxic to the neurons.

The existing techniques for the detection of amyloid plaques include positron emission tomography (PET) scans that are reported to be expensive and distressing to a patient.


Smith & Nephew to buy Rotation Medical for $210m

UK-based firm Smith and Nephew signed a definitive agreement to purchase US tissue regeneration technology developer Rotation Medical for a total of approximately $210m.

Intended to support Smith and Nephew’s growth strategy, the deal will see an initial cash consideration of $125m followed by up to $85m over the coming five years, based on financial performance.

Designed for repair of shoulder rotator cuff, Rotation Medical’s system features a technology that combines biomechanics and biology for improving the natural healing response of the body.