February's top stories: FDA approval of Abbot's MRI pacemaker, Hologic's acquisition of Cynosure

Abbott has secured the US FDA approval for magnetic resonance-conditional labelling of its Assurity MRI pacemaker, and Hologic has signed a definitive agreement to acquire medical aesthetics systems and technologies provider Cynosure for $1.65bn. Medicaldevice-network.com wraps-up the key headlines from February, 2017.


Philips launches new image-guided therapy platform Azurion

Netherlands-based health technology company Royal Philips expanded its existing portfolio of solutions with the launch of new image-guided therapy platform Azurion.

Meant for use in the interventional labs, Azurion features an ergonomic design with an easy-to-use user interface and is equipped with new workflow options, performance dashboards, as well as a range of productivity improvement services.

The platform includes 1,000 new components such as an improved flat-panel detector and the firm's new ConnectOS operating system, which enable integration of real-time information from all relevant technologies in the lab.

Abbott secures FDA approval for Assurity MRI pacemaker

Healthcare firm Abbott secured the US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling of its Assurity MRI pacemaker and Tendril MRI pacing lead.

Claimed to be the smallest and long-lasting wireless MRI-compatible pacemaker, Assurity MRI enables wireless remote monitoring, allowing secure access to patients' diagnostic data and daily device measurements as well as decreases the need for in-office visits.

A pacemaker is a small, low-voltage implantable device developed to monitor the heart's rate and rhythm, and delivers electrical stimulation when the heart beats too slowly.

Hologic to purchase medical aesthetics firm Cynosure for $1.65bn

Diagnostic products developer Hologic signed a definitive agreement to acquire all outstanding shares of medical aesthetics systems and technologies provider Cynosure for $1.65bn.

The transaction is expected to expand Hologic's scientific and commercial capabilities into the aesthetics segment of medical technology, while expanding Cynosure's customer reach and market.

Cynosure's portfolio includes 20 products across non-invasive body contouring, hair removal, skin revitalisation and women's health categories, which are marketed through direct sales and distributors in more than 130 countries.

Vention Medical to sell device manufacturing business to MedPlast

Vention Medical signed a definitive agreement to sell its device manufacturing business to medical device services provider MedPlast.

Financial details of the agreement have not been disclosed.

The transaction is expected to allow MedPlast to offer a range of services to medical device and equipment manufacturers, as well as strengthen its assembly and packaging capabilities.

Baebies secures FDA de novo clearance for SEEKER in newborn screening

Biotechnology company Baebies secured de novo clearance from the US Food and Drug Administration (FDA) for the use of its newborn screening platform SEEKER in diagnosis of lysosomal storage diseases (LSDs).

The new device is designed to quantitatively measure the activity of lysosomal enzymes α-L-iduronidase (IDUA), α-D-glucosidase (GAA), β-glucocerebrosidase (GBA) and α-D-galactosidase A (GLA) in dried blood spot samples of newborns.

The detection of a decrease in the activity of these lysosomal enzymes indicates the presence of LSDs such as Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher or Fabry.

Grifols acquires Hologic's blood screening business for $1.85bn

Spain-based healthcare company Grifols completed the acquisition of the US-based medical devices maker Hologic's interest in their joint-business for $1.85bn.

The acquired unit of Hologic is focused on research, development and manufacture of assays and instruments based on Nucleic Acid Testing (NAT) technology..

The NAT technology aids transfusion, transplantation screening and identification of infectious agents in blood and plasma donations.

Medrobotics closes $20m financing for surgical robotic technology

US-based medical device manufacturer Medrobotics closed a $20m preferred stock financing round, which included participation of its existing shareholders.

The firm intends to utilise the proceeds to upgrade and develop its Flex robotic system with more fully robotic instrument options, as well as to expand its surgical applications such as single-port general and gynecological surgeries.

The Flex robotic system is a robotic surgical platform with a steerable and shapeable robotic scope.

Cook Medical expands with new commercialisation and development centre in Brisbane

Medical device company Cook Medical opened a new $4m Asia Pacific commercialisation and development centre (ACDC) at Brisbane Technology Park in Australia.

A part of the firm's plan to boost R&D in the country, the new centre aims at helping businesses, entrepreneurs and researchers from across Asia Pacific in the commercialisation of new medical products and related technologies.

The  ACDC research partners can access its entire resources such as a fabrication laboratory with 3D printing capabilities, electrical and mechanical systems for testing products, business facilities, workshop and demonstration spaces.

Courtagen Life Sciences introduces 17 new tests for neurology and endocrinology

US-based diagnostic firm Courtagen Life Sciences introduced 17 new gene tests for neurology and endocrinology, expanding its current line of Spotlight tests.

The firm's Spotlight panels, which contain approximately three to 50 genes each, are developed for genetic testing when a patient's symptomology can be identified.

The selection of the genes depends on their ability to make test selection clear, by addressing a group of disorders with overlapping symptoms.

Masimo reports positive outcome from clinical study of PVi monitoring in colorectal surgery

Monitoring technologies provider Masimo reported positive outcome from a clinical study of Masimo PVi (Pleth Variability Index) monitoring in low-risk patients undergoing colorectal surgery.

PVi is a measure of the dynamic changes in perfusion index (PI), which take place during the respiratory cycle. Masimo PVi is designed to be continuous and non-invasive.

Conducted by Dr Warnakulasuriya and colleagues at York Teaching Hospital in York, UK, the study showed that PVi offers a non-invasive alternative for goal-directed therapy in this group of patients.