July’s top stories: Roche confirms CoaguChek XS System efficacy, LabCorp to acquire Sequenom

Roche confirms efficacy of CoaguChek XS System for patients on anticoagulation therapy, and Laboratory Corporation of America (LabCorp) has entered into a definitive agreement to acquire Sequenom for about $371m. Medicaldevice-network.com wraps up the key headlines from July 2016.


Roche confirms efficacy of CoaguChek XS System for patients on anticoagulation therapy

US-based medical device company Roche confirmed the safety and efficacy of the CoaguChek XS System for use by healthcare professionals at point of care and for patients to conduct self-tests at home.

Point-of-care and patient self-testing (PST) are increasing standards of care for patients on anticoagulation therapy who need regular prothrombin time (PT) / international normalised ratio (INR) tests.

With a convenient form of testing device, patients can adhere to their prescribed testing frequency while healthcare professionals can make timely treatment decisions.

LabCorp to acquire Sequenom for $371m

US-based healthcare diagnostics company Laboratory Corporation of America (LabCorp) entered into a definitive agreement to acquire US-based medical technology company Sequenom for a total enterprise value of about $371m.

LabCorp has created an acquisition subsidiary named Savoy Acquisition to complete the tender offer of purchasing all the outstanding shares of Sequenom valued at $2.40 each share.

Sequenom president and CEO Dirk van den Boom said: "Strategically, this transaction makes sense.

Natural Cycles fertility application to be regulated as medical device

Woman’s fertility application, Natural Cycles is designated as the first such health application to be regulated as a medical device.

Recently held clinical studies have likened the efficacy of Natural Cycles to that of a contraceptive pill in preventing pregnancies.

Health applications are considered to play an important role in a woman’s daily life as it furnishes information impacting their health and well-being.

Vasorum gets FDA approval for Celt ACD arterial closure device

Irish medical device research and development firm Vasorum secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its arterial puncture closure device Celt ACD to be used for both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients.

Celt ACD comes in three sizes and is meant for a single-use. It offers a safe and effective closure of 5F, 6F and 7F arterial punctures

The design of the device features versatility which enables the physicians to conduct multiple re-stick procedures thereby treating a wide range of clinical situations and patient anatomies.

ElectroCore’s nVNS therapy decreases chronic migraine attacks

US-based ElectroCore reported a positive outcome from the Event study conducted on non-invasive Gammacore vagus nerve stimulation (nVNS) therapy in treating patients with chronic migraine.

Gammacore involves a non-invasive procedure where a hand-held device issues an electrical signal.

A conductive gel is applied on the stimulation surfaces of the device which is then placed on the neck.

Viracor-IBT gets FDA emergency use authorisation of Zika Virus Real-time RT-PCR assay

Eurofins Scientific’s subsidiary Viracor-IBT Laboratories (Viracor-IBT) received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay.

Viracor-IBT’s patented molecular Zika virus test is a real-time RT-PCR assay designed to detect the RNA from the Zika virus in human serum, plasma, or urine derived from individuals meeting Zika virus clinical and epidemiological criteria.

The epidemiological criteria considers staying or travelling in a place with a history of Zika outbreak or other epidemiologic criteria for which Zika virus testing may be indicated.

DePuy Synthes and Materialise to introduce TRUMATCH titanium 3D-printed implants

US-based medical device company DePuy Synthes entered into an agreement with 3D printing company Materialise to introduce TRUMATCH titanium 3D-printed implants for facial and skull disorders.

The new titanium 3D-printed implants will offer a personalised solution for orthognathic surgery and other craniofacial indications.

The device easily integrates with virtual surgical planning, intraoperative patient specific tools and personalised implants which enables surgeons to offer better patient outcomes.

Penumbra introduces stroke thrombectomy technology ACE 68 Reperfusion Catheter

US-based medical device company Penumbra commercially introduced its thrombectomy device, the ACE 68 Reperfusion Catheter in the US.

The catheter is based on the latest technology to offer maximum aspiration power in an easy and safe way for extracting thrombus in acute ischemic stroke patients.

The device features a coil winding geometry along 16 transitions to promote an optimum tracking profile which is done through tortuosity characterising an acute ischemic stroke in patients.

Fisher Center scientists develop 3D visualisation of brain defects causing Alzheimer's disease

Fisher Center scientists have created imaging technology that enables 3D visualisation of the brain defects that cause Alzheimer's disease.

The technology, which has been funded by the Fisher Center for Alzheimer's Research Foundation, enables visualisation of amyloid plaques, as well as other alzheimer's hallmarks, such as tau, vasculature and microglia activation, in a large volume, in an entire mouse brain with the potential of application on frozen human brain samples.

Fisher Center for Alzheimer's Research Foundation president and CEO Kent Karosen said: "We are proud that the funding we provide has resulted in innovative, never before seen imaging of what causes Alzheimer's disease.

Bayer introduces pain relief Aleve Direct Therapy

Medical device company Bayer has introduced pain relief device Aleve Direct Therapy in the US.

Aleve Direct Therapy uses the same transcutaneous electrical nerve stimulation (TENS) technology used by doctors to provide patients with deep penetrating relief at the source of lower back pain.

A non-invasive, drug-free method of controlling pain, TENS  works by delivering stimulating pulses at the site of pain.