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Baylis Medical Company Inc. will be acquired by Boston…
Baylis Medical Company Inc. has agreed to be acquired by Boston Scientific Corporation for a $1.75 billion upfront payment, subject to closing adjustments. As part of this acquisition, Boston Scientific will have access to radiofrequency platforms NRG® and VersaCross® Transseptal, along with items such as sheaths, guidewires and dilators that are designed to support left heart access. The transseptal protocols of these platforms enable surgeons to increase safety, efficacy and efficiency when they cross the atrial septum to carry out therapies on the left side of the heart, including operations like atrial fibrillation ablation and LAAC closure, as well as processes like mitral valve interventions. After achieving year-over-year sales growth in the double digits each of its past five years, Baylis Medical Company is expected to generate revenues approaching $200 million by 2022. Mike Mahoney, the chief executive officer and chairman of Boston Scientific, commented: "The talented and innovative Baylis Medical Company team, combined with these transseptal platforms, will enhance our efforts to improve procedural efficiencies with physician tools designed to make left atrial access safer and more predictable, with a focus on patient outcomes. A leader in many of the fastest growing markets in our industry, we believe that Baylis Medical Company will add meaningful revenue, operating income, and new research and development capabilities across multiple Boston Scientific businesses, while complementing existing offerings within our electrophysiology and structural heart portfolios." Medical professionals have traditionally injected medicine into the left side of the heart using a mechanical needle that passes through the septum. This can present safety concerns and placement challenges, depending on the patient's anatomy. Instead of depending on mechanical force alone, Baylis Medical Company platforms use RF energy in order to achieve safe and predictable transseptal access. This method increases efficiency, improving the safety and efficacy of transseptal puncture while left heart procedures take place. Using VersaCross, therapeutic delivery of transseptal crossing procedures can be further optimized. By eliminating potential wire and sheath exchanges, the VersaCross platform may help mitigate risk during procedures. A 510(k) clearance was granted by the Food and Drug Administration (FDA) for Baylis Medical Company's NRG platform in 2008, and since then has been used in more than one million procedures
FDA Approves First CT System Based On Photon Counting
FDA Approves First CT System Based On Photon Counting September 30 saw the U.S. Food and Drug Administration (FDA) approve the Siemens Naeotom Alpha, the first CT scanner in the world that counts photons. It is the biggest shift in CT technology for this workhorse radiology modality in years. According to both the FDA and CT experts, the development represents the start of a revolution in CT scanner technology. Laurel Burk, PhD, assistant director of the Diagnostic X-ray Systems Team in the FDA’s Center for Devices and Radiological Health, said in a press release: “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures, and monitoring the effectiveness of certain therapies. Today’s action represents the first major new technology for computed tomography imaging in nearly a decade and underscores the FDA’s efforts to encourage innovation in areas of scientific and diagnostic progress.” This device uses the newly emerging photon-counting technology of CT detectors, which measures each individual X-ray photon passing through a patient's body, but does not use the technology used in current devices, which measure the total energy of several photons at once. Each photon in the X-ray can be counted in order to obtain detailed information about the patient, so that less unhelpful information, like image noise, is included in the images. New photon-counting detectors offer advantages over conventional CT detectors because of their active detection layers. The current CT technique uses a scintillator layer within the detector to convert X-ray photons into visible light, and then photo diode sensors transform the visible light into digital signals. As a result, energy information about the X-rays is lost and can no longer aid in diagnosis, as well as contrast being reduced, leading to less clear images. With photon-counting detectors, X-rays are directly converted into electrical current, so no visible light is needed to detect them. Based on different kilovolt (kV) energy levels, the thresholds of each pulse can be collected and binned as appropriate. The formula creates dual-energy, spectral imaging data, which improves contrast and sharpens images, and direct conversion assists with decreases in information loss and improves image quality.
Launch of MHRA Public Consultation Over Medical Device Regulation
By launching a consultation on medical device regulation, as well as establishing a work program for software and artificial intelligence (AI), the UK Medicines and Healthcare Products Regulatory Agency has advanced its efforts to create a post-Brexit regulatory environment. Since the EU's Medical Device Regulation was not implemented in the UK before the Brexit transition period ended, the UK will develop its own regulatory strategies for the medical devices industry. A new approach to regulation has already been laid in the Medicines and Medical Devices Act 2021, informed by the findings of the independent Cumberlege Review, and MHRA plans to use its new powers to amend UK regulations surrounding medical devices. To gather feedback on the proposals, the government released a consultation document that contains 17 chapters. The document covers every aspect of medical device regulation in the UK, with one chapter addressing how medical devices are classified. A medical device in UK is classified into Class I, IIa, IIb, or III, depending on its risk level. MHRA has decided to assign separate risk categories to a few devices while retaining the basic structure. The chief executive of the MHRA, Dr June Raine, says: “The launch of this consultation is an exciting step towards a more robust, world-leading regulatory framework for medical devices in the UK, one that enhances medical device safety and quality, access to devices, and has patients at its heart. We know that a problem with a medical device can have a significant impact on people’s lives. This consultation offers a once in lifetime chance to help shape the regulations. In order to reach this goal, we want to hear from a wide range of people. Delivering for patients is central to our work and we fully recognise the importance of the public and patients’ perspectives and encourage them to share their views during this consultation. From pacemakers to contact lenses, wheelchairs to pregnancy tests, medical devices play a vital role for the vast majority of us and I encourage everyone who wants to be a part of this mission to put forward their views.”
GE Healthcare acquires BK Medical With Expansion of Ultrasound…
BK Medical, a company dedicated to advanced surgical visualization technology, will be acquired by GE Healthcare for $1.45 billion, the two companies announced Thursday. In addition to having offices in Boston, BK Medical also has a presence in Copenhagen, Denmark, and specializes in intraoperative imaging and surgical navigation, with the aim of giving doctors visual access inside the patient's body during surgery. In minimally invasive and robotic surgeries, as well as during procedures in neurosurgery, abdominal surgery, and ultrasound urology, BK Medical provides the high quality imaging and navigation that are crucial to success. By partnering with GE, the healthcare giant will expand the $3B business beyond its current diagnostic ultrasound program to include the entire range of ultrasound imaging. This acquisitions means With this acquisition, BK Medical's Active Imaging platform can reach new audiences around the world, and the combined diagnostic imaging and surgical visualization capabilities of GE Healthcare and BK Medical will allow better decision-making across the care continuum. BK Medical is expected to continuously grow revenue via margin expansion and free cash flow growth, GE said, forecasting “high-single-digit” returns within 5 years on its invested capital. Regulatory agencies have not yet approved the transaction, but it is expected to close by 2022. Kieran Murphy, President and CEO of GE Healthcare, said: “Ultrasound today forms an integral part of many care pathways, and BK Medical is a strategic and highly complementary addition to our growing and profitable ultrasound business. This transaction helps GE Healthcare continue to expand beyond diagnostics into surgical and therapeutic interventions, simplifying decision-making for clinicians and equipping them with greater insights to deliver faster, more personalized care for their patients—representing another step toward delivering precision health.” Brooks West, BK’s CEO and President, added: “We are immensely proud of the organization and of the life-changing technology that we have built at BK Medical and look forward to our future as part of the GE Healthcare family. Our mission to help surgeons make critical decisions using active imaging aligns well with GE Healthcare’s mission to help physicians make more informed decisions and improve patient outcomes, and we are eager to begin this new chapter.”